Clinical trial NCT06358820
Conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Keywords: amino acid peritoneal dialysis solution；peritoneal dialysis
Sponsor: The People's Hospital of Gaozhou
Start date: 2023-12-03; Completion date: 2025-01-07
Enrollment: 149 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.

Detailed description:

Arms: arm 1: Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.
Interventions: intervention 1: Amino acid peritoneal dialysis solution
Intervention descriptions: intervention 1: Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months

Protocol documents:
Prot_SAP_000.pdf: 
Clinical trial protocol
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Clinical study protocol
Programme No.: ajsfmtxy001
The effect of amino acid peritoneal dialysis fluid on the nutritional
status of patients with maintenance peritoneal dialysis was investigated
Efficacy and safety: a multicenter, open, prospective, self-controlled clinical trial
research
Peritoneal dialysis Center, Gaozhou People's Hospital
Programme date: 30 September 2023
Version number: 1.0
Confidentiality statement
The content included in this document, especially unpublished data, is owned by the Gaoyang People's
Hospital Peritoneal Dialysis Center. It is provided to you under confidentiality for review by the Ethics
Committee/Institutional Review Board. Please remember that, except when necessary to obtain informed
consent from patients who may receive trial treatments, the content of this document must not be disclosed to
any other person or entity without written approval from our institution.


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scenario summary
title
To explore the effectiveness of amino acid peritoneal dialysis fluid in
improving the nutritional status of patients undergoing maintenance
peritoneal dialysis and safety: a multicenter, open, prospective, self-
controlled clinical study
Applicant
Peritoneal dialysis Center, Gaozhou People's Hospital
purpose of
research
To explore the effectiveness and safety of amino acid peritoneal dialysis
fluid on the nutritional status of peritoneal dialysis patients
performance assessment
research design Multicenter, open, prospective, self-controlled study
Study duration
Each subject will be studied for six months, and the entire study will be
completed in about a year.
Number of
researchers
140 patients with malnutrition were selected for peritoneal dialysis
Center number
Five centres are expected
Main research
unit
Peritoneal dialysis Center, Gaozhou People's Hospital
Criteria for
inclusion
1. Patients with malnutrition in uremia were screened and maintained
peritoneal dialysis for at least 3 months. The criteria for malnutrition
should meet at least 2 of the following items:(1) serum albumin level
<3.5g/dL (35g/L), (2) prealbumin <300mg/L, (3) modified Good Law
Subjective Comprehensive Nutritional Assessment (Subjective Global
Assessment, SGA)> 7 points;
2. Blood urea nitrogen less than or equal to 38mmol/L;
3. The patient's age is between 18 and 75;
4. The patient signs the informed consent form.


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Exclusion
criteria
1. Allergy to any amino acid or excipient in this product;
2. Have had peritonitis more than once in the last 3 months; have had
peritonitis in the last 1 month inflammation or hospitalization;
3. Combine hyperthyroidism, systemic infection fever and other high
metabolic state diseases, as well as taking medication drugs that affect
tissue metabolism, such as corticosteroids;
4. Congenital amino acid metabolic defects, acute severe pancreatitis,
severe hyperbilirubinemia
5. Malignant tumor metastasis or diffusion, residual cancer after
treatment,
coagulation
dysfunction,
regeneration
patients
with
obstructive anemia, severe diseases of other systems such as heart, brain
and lung;
6. Kidney transplant may be accepted during the trial;
7. Active hepatitis B or C, cirrhosis, active liver disease, liver
dysfunction
or human immunodeficiency virus (HIV) serum reaction positive;
8. Participants who have participated in other drug clinical trials within 3
months before enrollment;
9. Pregnant and lactating women;
10. The mental state cannot cooperate;
11. No written informed consent has been signed;
12. Unable or unwilling to comply with the protocol approved by the
investigator;


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The patient
withdrew
Participants can withdraw from the study under any circumstances and
should do so in the following situations withdrawal studies:
(1) The patient develops life-threatening complications;
(2) The occurrence of intolerable clinical symptoms related to the
therapeutic drug;
(3) Pregnancy was combined during the study;
(4) Violation of the test plan;
(5) Unwilling to continue participation in the study;
(6) Disappearance.
Study treatment
Each subject received a daily dose of 1 bag of amino acids for 6 months
plus 2-4 daily treatment with bagged glucose peritoneal dialysis fluid.
Research process
Each subject received a 6-month treatment of 1 bag of amino acid
peritoneal dialysis and 2-4 bags of glucose peritoneal dialysis fluid per
day (the amount of glucose peritoneal dialysis fluid was determined
according to the treatment protocol at screening when the patient entered
the study). Before and during treatment, in the 1st, 3rd and 6th months,
the subjects were evaluated for various efficacy and safety indicators
Estimate and record any adverse events or serious adverse events.
Follow up monthly during treatment assess subjective feelings (infusion
pain, abdominal distension), blood pressure, weight, urine volume, and
ultrafiltration.


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Endpoint of
efficacy
Efficacy indicators: serum albumin, prealbumin and body mass, body
mass index (Body mass index, BMI), lean body mass index (con icity
index, CI), waist circumference and grip strength, upper arm muscle
circumference, standardized protein catabolic rate (Normalized protein
catabolic rate, nPCR), standardized protein total nitrogen excretion rate
(Normalized protein nitrogen appearance,nPNA). Glycated hemoglobin,
fasting blood glucose, Nt-pro BNP, weekly urea clearance index (Kt/V),
weekly creatinine clearance (Ccr), and oral glucose tolerance test
(peritoneal equilibration test, PET）
Security
assessment
Safety indicators: patient blood pressure, ultrafiltration volume, urine
volume, Nt-pro BNP, Kt/V, Ccr, PET, adverse event monitoring.


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statistical
analysis
analytic set
Full analysis set (Full Analysis Set, FAS): All with at least one exposure
subjects studied for treatment. This analysis set will be used primarily
for the analysis of baseline data. Set of Safety Analyses (Safety Analysis
Set, SS): At least one study was accepted all subjects treated and with a
record
of
safety
after
medication.
Effectiveness
Analysis
Set
(Effectiveness Analysis Set, EAS): All subjects included received at least
one study treatment and had at least one post-treatment observation
subjects for the evaluation of the effectiveness of the intermediate point.
statistical analysis technique
Continuous variables will be statistically described according to the data
distribution, including number of cases (non-missing), mean, standard
deviation, median and quartiles, maximum and minimum values.
Calculate the number and percentage of each category of categorical
variables.
Main endpoint: Descriptive analysis was used to summarize baseline,
post-treatment 6 months albumin and prealbumin measurements, and the
difference in change from baseline of enrolled subjects. Paired t-tests
were used to test for differences before and after treatment, and multiple
problems were controlled by Hochberg method.
Secondary endpoints: Descriptive analysis will be used to summarize the
baseline, three months post-treatment, and six months post-treatment
nutritional status, metabolic status, residual renal function, and trends in
dialysis adequacy for enrolled subjects, with graphical presentations;
Tests for changes relative to baseline: For continuous variables, paired t-
tests or Wilcoxon's signed-rank test will be used to compare pre-and post
-treatment differences based on data distribution; for categorical


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variables, McNemar-tests will be used to compare the behavior before
and after.
Safety analysis: Descriptive statistics were used to summarize adverse
events
and
adverse
reactions,
drug-related
treatment
measures,
outcomes,
and
severity
classification.
Subgroups
were
used
if
necessary(For example, whether dialysis is adequate or heart failure)
stratified analysis of data was performed.
Exploratory analysis: patients were divided into adequate and inadequate
groups according to baseline Kt/V≥1.7. The improvement of nutritional
indicators in different subgroups was analyzed.


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catalogue
Efficacy and safety: a multicenter, open, prospective, self-controlled clinical trial research1
scenario summary................................................................................................................. 1
1. Research background........................................................................................................9
2. Research objectives.........................................................................................................12
2.1 Main objectives......................................................................................................12
2.2 Secondary objectives............................................................................................. 12
2.3 Exploratory purposes............................................................................................. 12
3. Test design.......................................................................................................................13
3.1 Research design..................................................................................................... 13
3.2 Study endpoints and evaluation criteria.................................................................15
3.2.1 Main end indicators......................................................................................15
3.2.2 Secondary endpoints....................................................................................15
3.2.3 Exploratory end point indicators..................................................................17
3.3 Criteria for patient selection and exclusion........................................................... 17
3.3.1 Selection criteria.......................................................................................... 17
3.3.2 Exclusion criteria......................................................................................... 17
3.3.3 Exit criteria...................................................................................................18
4. Research plan..................................................................................................................18
4.1 Research phase and process...................................................................................18
4.2 Data collection....................................................................................................... 25
4.2.1 Screening period.......................................................................................... 25
4.2.2 During treatment..........................................................................................27
5. Treatment plan................................................................................................................ 27
5.1 Research treatment.................................................................................................27
5.1.1 Treatment protocol.......................................................................................27
5.1.2 Treatment dose adjustment.......................................................................... 28
5.2 Adjuvant therapy/combined medication................................................................ 29
5.3 Treatment compliance............................................................................................30
6. Adverse events................................................................................................................ 30
6.1 Definition of adverse events.................................................................................. 30
6.2 Observation and handling of adverse events......................................................... 31
6.3 Criteria for judging the relationship between adverse events and tests.................32


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6.4 Evaluation of adverse reactions............................................................................. 32
6.5 Reporting of adverse events...................................................................................33
7. Statistical considerations.................................................................................................33
7.1 Sample size calculation..........................................................................................33
7.2 analysis set............................................................................................................. 34
7.3 stochastic................................................................................................................34
7.4 General analysis considerations.............................................................................35
7.5 Missing data...........................................................................................................35
7.6 Statistical analysis methods................................................................................... 35
7.6.1 Demographic and baseline status, compliance, medical history, and analysis
of concomitant disease treatment..........................................................................35
7.6.2 Statistical analysis of the primary endpoint.................................................36
7.6.3 Statistical analysis of secondary endpoints..................................................36
7.6.4 safety analysis..............................................................................................36
7.6.5 Exploratory analysis.....................................................................................37
7.7 Multiplicity issues..................................................................................................37
8.Ethical norms................................................................................................................... 37
8.1 Ethical review........................................................................................................ 37
8.2 Informed consent................................................................................................... 38
8.3 Protection of subjects' rights and interests.............................................................38
8.4 Data quality and security supervision....................................................................39
9. Quality assurance............................................................................................................39
9.1 Requirements for project leader.............................................................................39
9.2 Requirements for researchers.................................................................................40
9.3 Quality control of treatment plan formulation and implementation...................... 41
10. Data processing and data preservation..........................................................................41
10.1 Case Report Form (CRF).....................................................................................41
10.2 Establishment of databases.................................................................................. 42
10.3 Preservation of information................................................................................. 43
11. Clinical research sponsor.............................................................................................. 44
12. Work progress............................................................................................................... 44
References...........................................................................................................................45


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1. Research background
Peritoneal dialysis is a treatment method that uses the peritoneum as a semipermeable
membrane. By injecting dialysate into the abdominal cavity, metabolic waste and excess
water in the blood are allowed to permeate and diffuse into the dialysate, which is then
drained from the body. This process helps remove toxins from the body and regulate
electrolyte balance. Peritoneal dialysis has several advantages, including ease of operation,
no need for an intravenous access, minimal impact on hemodynamics, the ability to
preserve residual kidney function, and the flexibility to control treatment time and location.
It is widely used as a substitute for kidney therapy in patients with end-stage chronic renal
failure method.
However, long-term peritoneal dialysis can also lead to some adverse consequences,
one of which is malnutrition. Malnutrition refers to a state where the nutrients ingested or
absorbed by the body cannot meet its physiological needs, leading to dysregulation in the
body's composition, function, or metabolism. Malnutrition is very common among
patients undergoing maintenance peritoneal dialysis, with an incidence rate as high as 20%
to 70%. The causes of malnutrition are numerous, including metabolic disorders due to
reduced kidney function, decreased appetite, gastrointestinal symptoms, restricted diets,
and medication use. Additionally, peritoneal dialysis itself can exacerbate the development
of malnutrition its development is mainly manifested in: loss of proteins and amino acids:
about 5 to 15g of protein is excreted daily through peritoneal dialysis fluid, of which about
half is albumin. At the same time, about 10 to 20g of free amino acids are lost daily. These
proteins and the loss of amino acids leads to negative nitrogen balance and decreased
serum albumin levels.
Glucose
absorption:
Conventional
peritoneal
dialysis
fluids
contain
high
concentrations of glucose as a osmotic agent to increase the amount of water filtered.
However, these glucose are also absorbed by the body, about 80-120g per day. These
additional energy intake can lead to metabolic disorders such as obesity, hyperinsulinemia,
insulin resistance and diabetes.
Inflammatory response: long-term peritoneal dialysis will cause chronic micro-
inflammatory response, resulting in increased catabolic metabolism, reduced synthetic
metabolism, decreased appetite, endocrine dysfunction and so on. At the same time,
inflammatory response will also affect vascular permeability
and hemodynamics,
reducing ultrafiltration efficiency and the ability to remove toxins.


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Malnutrition not only affects the quality of life of peritoneal dialysis patients, but also
increases the risk of complications such as infection, cardiovascular events, and peritoneal
failure, reducing survival rates. Therefore, improving the nutritional status of peritoneal
dialysis patients,
It is one of the important measures to improve its prognosis and quality of life.
Currently, nutritional support strategies for peritoneal dialysis patients mainly include
oral nutritional supplementation, enteral nutrition supplementation, parenteral nutrition
supplementation, and modified peritoneal dialysate. Among these, modified peritoneal
dialysate refers to adding beneficial components such as amino acids, ketones, and low-
osmolarity agents to conventional glucose-containing peritoneal dialysate. This reduces
glucose absorption, increases the clearance of water and toxins, provides essential amino
acids and energy, and improves the body's metabolic function
Check your physical and nutritional status.
Amino acids are the fundamental units for protein synthesis and other important
substances in the body, and they also serve as one of the key energy sources for oxidative
metabolism. Amino acid peritoneal dialysate is a sugar-free and osmotic agent-free
peritoneal dialysate containing 1.1% (11 g/L) free amino acids, with an amino acid
composition similar to that found in human plasma. The main mechanisms of action of
Amino acid peritoneal dialysis fluid are as follows: supplemental amino acids: Amino acid
peritoneal dialysis fluid can provide amino acids to the blood through peritoneal diffusion,
thus to compensate for the loss of protein and amino acids, increase serum albumin level,
improve the body nitrogen balance and nutritional status.
Providing Energy: Amino acid peritoneal dialysate can serve as a sugar-free osmotic
agent, moving water from the blood to the dialysate through osmotic pressure differences,
thus achieving ultrafiltration. At the same time, amino acids can be absorbed by the body
and participate in energy metabolism, providing about 40kcal of energy daily. This not
only reduces the need for high-concentration glucose. Sugar dependence can also avoid
the metabolic disorder caused by excessive absorption of glucose.
Metabolic Regulation: Amino acid peritoneal dialysis fluid can influence the
secretion and activity of various hormones and cytokines in the body, thereby regulating
metabolism. For example, amino acids can stimulate the secretion of insulin, glucagon,
growth hormone, and insulin-like growth factor-1, promoting glucose utilization and
protein synthesis; amino acids can also inhibit the secretion of tumor necrosis factor- α and
interleukin-6, etc., inhibits inflammatory response and protein breakdown.


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Amino acid peritoneal dialysate, as an improved version of peritoneal dialysate, has
been clinically applied and studied in many countries and regions both domestically and
internationally. Currently, numerous studies have confirmed the beneficial effects of
amino acid peritoneal dialysate on the nutritional status of patients undergoing
maintenance peritoneal dialysis [1-10]. For example, Sun Bin [1] et al. investigated the
impact of amino acid peritoneal dialysis on the dialysis efficiency and nutritional status of
peritoneal dialysis patients. The results showed that amino acid peritoneal dialysis can
increase serum albumin levels, reduce urea nitrogen, uric acid, and blood phosphorus
levels, and elevate hemoglobin levels, thereby improving the nutritional status of patients.
Sun Yuling[3] et al. compared the effects of amino acid peritoneal dialysate and traditional
glucose peritoneal dialysate on peritoneal mesothelial cells, finding that amino acid
peritoneal dialysate better maintains cell viability, adhesion function, and protein synthesis.
Faller[6] et al. treated peritoneal dialysis patients with optimized 1.1% amino acid
peritoneal dialysate for 3 months and observed significant increases in serum albumin and
transferrin levels. Jones [7] et al. found that compared to glucose dialysate, amino acid
dialysate can improve albumin, prealbumin, and transferrin levels in malnourished
peritoneal dialysis patients, and also observed improvements in muscle nutrition indicators.
Delarue[9] et al. studied the impact of amino acid dialysate on creatine metabolism and
found that amino acid dialysate can stimulate creatine release and increase protein
synthesis. Li[10] et al. conducted a 3-year randomized controlled study, and the results
showed that long-term use of amino acid dialysate can improve the nutritional status of
peritoneal dialysis patients, especially for female patients.The above studies show that
amino acid peritoneal dialysis fluid can effectively improve the nutrition of patients with
maintenance peritoneal dialysis.
The state of temperament and metabolism promotes its growth and development and
physical improvement. However, a meta-analysis in 2021 [13]comprised a review of
6,945 abstracts, including 14 studies (9 randomized and 5 non-randomized), concluded
that amino acid peritoneal dialysate may not alter anthropometric indicators, the impact on
serum albumin is uncertain, and the estimated differences are unlikely to have clinical
significance. However, due to the low quality of evidence, these findings should be
interpreted with caution. Based on the above meta-analysis, robust research is needed to
address the limitations in the evidence. Therefore, we propose a multicenter, open,
prospective, self-controlled clinical study aimed at observing the effects of amino acid


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peritoneal dialysate on the nutritional status of patients undergoing maintenance peritoneal
dialysis, as well as its safety assessment, with a view to promoting its clinical application
The application provides stronger evidence. The characteristics of this study are as
follows:
Multicenter: This study will be conducted in five different regions of Guangdong
province to improve the study its universality and representativeness.
Open: This study will not have a placebo or control group, but will use a self-control
design, that is, each subject will be compared with the observation indicators before and
after receiving amino acid peritoneal dialysis treatment to reduce individual differences
and the influence of interfering factors.
Prospective: A detailed study protocol will be developed before the formal start of the
study and will be carried out in accordance with the protocol. Record, report and other
work to ensure the quality and credibility of the research.
Self-control: This study will use a self-control design, that is, each subject will
receive amino acid peritoneal dialysis. The comparison of observation indicators before
and after exudation therapy was carried out to reduce the influence of individual
differences and other interfering factors.
2. Research objectives
2.1 Main objectives
The main purpose of this study was to evaluate the nutritional status of patients
undergoing maintenance peritoneal dialysis with amino acid peritoneal dialysate the effect
of improvement.
2.2 Secondary objectives
The secondary aim of this study was to explore the metabolic status of patients
undergoing maintenance peritoneal dialysis with amino acid peritoneal dialysate effects
on residual renal function, dialysis adequacy and safety.
2.3 Exploratory purposes
According to Kt/V≥1.7, patients were divided into dialysis adequate and non-dialysis
adequate groups, and the effects of amino acid peritoneal dialysate on the nutritional status
of patients with dialysis adequacy were explored; according to Nt-pro BNP levels, patients


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were divided into non-heart failure groups and heart failure groups for further exploration
safety of amino acid peritoneal dialysis fluid.
3.Testdesign
The experimental design of this study is as follows:
3.1 Research design
This study adopts a multicenter, open, prospective, and self-controlled design, where
each participant serves as their own control before and after receiving amino acid peritoneal
dialysis fluid treatment, to compare changes in their nutritional status. This study does not
set up a placebo or control group, as amino acid peritoneal dialysis fluid is already on the
market, with its efficacy and safety proven, and there are no equivalent alternatives. The
primary objective of this study is to observe the nutritional improvement effects and safety
assessment of amino acid peritoneal dialysis fluid for malnourished peritoneal dialysis
patients. Specific techniques
The route is shown in Figure 1:


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Figure 1. Technical route
Criteria for inclusion
Exclusion criteria
Patients on maintenance peritoneal
dialysis
Qualified patients
Informed consent is signed for qualified cases
agree
Baseline data were collected, with 1 bag of amino acid peritoneal
dialysis fluid + 2-4 bags of glucose peritoneal dialysis fluid per day
Collect data, 1 bag of amino acid peritoneal dialysis fluid +2-
4 bags of glucose peritoneal dialysis fluid per dayof glucose
peritoneal dialysis fluid per day
Collect complete test data
statistical analysis
Draw conclusions from the study
Three months later
Six months later


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3.2 Study endpoints and evaluation criteria
3.2.1 Main end indicators
The primary endpoint of this study was the improvement of nutritional status of
subjects after 3 months and 6 months of treatment,
it includes the following two
indicators:
1) Serum albumin (g/L): the change value of serum albumin compared with baseline
at 3 months and 6 months after treatment (Δ serum albumin);
2) Prealbumin (mg/L): the change value of prealbumin at 3 months and 6 months
after treatment. The change value of prealbumin compared with the baseline after month
(Δprealbumin);The treatment was considered effective if the difference in change from
baseline for any of the above indicators was statistically significant.
3.2.2 Secondary endpoints
The secondary endpoint of this study was other relevant indicators of the subjects at 3
months and 6 months after treatment
The body is as follows: Mass (kg): The change in mass of the subject compared to
baseline at 3 months and 6 months(Δ Body mass); BMI (kg/m2): (Δ of the change in BMI
of the subject compared to baseline at 3 months and 6 months BMI); CI: CI change value
of the subject at 3 months and 6 months compared with baseline (ΔCI);
●
Waist circumference and grip
strength (cm/kg): The changes
in waist
circumference and grip strength compared with baseline at 3 months and 6 months were
measured by a tape measure to measure the circumference of the narrowest part of the
subject. The maximum grip strength of the subjects was measured with a grip strength
gauge;
●Arm muscle circumference (cm): The change in arm muscle circumference (Δ arm
muscle circumference) of the subjects compared with baseline at 3 months and 6 months
was measured by a tape measure at the midpoint of the subject's upper arm and according
to the formula
The calculated upper arm muscle circumference = arm circumference (cm) 0.3142 ×
triceps skinfold thickness (mm);
ΔnPCR (g/kg/d): nPCR change values of subjects at 3 months and 6 months
compared to baseline(ΔnPCR);


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ΔnPNA (g/kg/d): Changes in nPNA compared to baseline at 3 months and 6 months
Value (ΔnPNA).
3) Metabolic status-Glycated hemoglobin (%): Glycated hemoglobin of the subjects
at 3 months and 6 months compared to baseline White change value (Δglycosylated
hemoglobin) was measured by an automatic biochemical analyzer to measure the
glycosylated hemoglobin of the subjects Hemoglobin levels.
4) Fasting blood glucose (mmol/L): Fasting blood glucose of the subjects at 3 months
and 6 months compared with baseline
Change value (Δ fasting blood glucose) was measured by an automatic biochemical
analyzer to measure the subject's fasting blood glucose level.
5) Indicators of residual renal function and dialysis adequacy
●Urine volume: the change in urine volume compared with baseline at 3 months and
6 months (Δ urine volume);
●Ultrafiltration: change in urine volume compared to baseline at 3 months and 6
months (Δ ultrafiltrationmeasure);
Kt/V: The change value of Kt/V compared with the baseline at 3 months and 6
months (ΔKt/V), calculated by the formula Kt/V= (V × Ln(C0/C1) + (V × UF)/C1)/V,
where V is the body volume, C0 is the urea nitrogen concentration before infusion, C1 is
the urea nitrogen concentration after outflow, and UF is the ultrafiltration measure;
Ccr (L/week): the change value of Ccr compared with baseline at 3 months and 6
months (Δ Ccr), calculated by the formula Ccr= (U × V)/P, where U is the concentration
of urinary creatinine and V is the urine volume,P is serum creatinine concentration;
●PET: PET change values (ΔPET) at 3 months and 6 months compared to baseline
The formula PET= (D/P) × 100% was used to calculate the concentration of
substances in the effluent D and P . The concentration of a substance in a filling liquid.
6) Capacity load index
Nt-pro BNP: Nt-pro BNP change values at 3 months and 6 months compared to
baseline (ΔNt-pro BNP); the level of Nt-pro BNP in subjects was measured by
electrochemiluminescence.
7) Safety endpoint (adverse event): assessed according to vital signs, physical
examination, laboratory tests, etc.


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3.2.3 Exploratory end point indicators
This study did not set up a separate exploratory endpoint indicator, for exploratory
purposes of the indicator (nutritional status and safety comprehensive indicators) are the
same as the primary and secondary endpoints.
3.3 Criteria for patient selection and exclusion
This study will be conducted in a multicenter design with five centers expected to
enroll 140 subjects.
The inclusion, exclusion and withdrawal criteria of patients in this study are as
follows:
3.3.1 Selection criteria
1. Select patients with uremia with malnutrition during the screening period and
maintain peritoneal dialysis for at least 3 months. Malnutrition
The standard shall at least meet two of the following items:
(1) Serum albumin level <3.5g/dL (35g/L),
(2) Prealbumin <300mg/L,
(3) Subjective comprehensive nutritional assessment (SGA)> 7 points;
2. Blood urea nitrogen ≤38mmol/L;
3. The patient is between 18 and 75 years of age;
4. The patient signs an informed consent form.
3.3.2 Exclusion criteria
1. Allergy to any amino acid or excipient in this product;
2. Have had peritonitis more than once in the last 3 months; have had peritonitis or
been hospitalized in the last 1 month;
3. Combine hyperthyroidism, systemic infection fever and other diseases of high
catabolic state, as well as taking drugs that affect tissues
Metabolic drugs, such as corticosteroids;
4. Congenital amino acid metabolic defects, acute severe pancreatitis, severe
hyperbilirubinemia;
5. Malignant tumor metastasis or diffusion, residual cancer after treatment,
coagulation dysfunction, aplastic anemia, etc
Patients with serious diseases of other systems such as heart, brain and lung;


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6. Kidney transplant may be accepted during the trial;
7. Active hepatitis B or C, cirrhosis, active liver disease, liver dysfunction or human
immunodeficiency
The serum test for the defective virus (HIV) was positive.
8. Participants who have participated in other drug clinical trials within 3 months
before enrollment;
9. Pregnant and lactating women;
10. A person who is not fit to cooperate;
11. No written informed consent was signed;
12. Inability or unwillingness to comply with the protocol approved by the
investigator.
3.3.3 Exit criteria
Participants may withdraw from the study under any circumstances and should
withdraw from the study in the following situations:
(1) The patient developed life-threatening complications;
(2) The occurrence of intolerable clinical symptoms related to the therapeutic drug;
(3) Pregnancy was combined during the study;
(4) The subject was assessed by the investigator as needing to withdraw from the trial;
(5) Unwilling to continue to participate in the study/informed consent withdrawal;
(6) Disappearance.
If the subject wishes to discontinue participation in the study, he/she will participate
in the termination visit to complete the test items of the termination visit.
4. Research plan
4.1 Research phase and process
This study plans to enroll 140 patients with maintenance peritoneal dialysis who
meet the inclusion and exclusion criteria, and is expected to be conducted in 5 centers.
The study period for each subject is 6 months, and the entire study project will be
completed in about 1 year. The study was divided into two phases: screening and
treatment.
Screening period: Within 1 month before enrollment, patients who meet the inclusion
criteria
are
initially
screened,
including
physical
examination,
blood
pressure


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measurement, body weight measurement, BMI calculation, CI calculation, skinfold
thickness measurement, waist circumference and grip strength measurement, upper arm
muscle circumference measurement, SGA score, urine volume, ultrafiltration volume,
biochemical and liver and kidney function tests, serum albumin, prealbumin, nPCR,nPNA,
Kt/V and Ccr, Nt-pro BNP, hepatitis B related antigen and antibody, hepatitis C antibodies,
HIV antibodies and other indicators were measured, and subjective nutritional score (SGA)
and PET tests were performed. At the same time, explain the purpose, method, benefits
and risks of this study to the patient and obtain his/her written informed consent. At the
same time, inform the patient
The patient introduces the specific protocol and precautions of this study.
Treatment Phase: The treatment phase begins after enrollment. Each participant
receives a regimen of 1 bag of amino acid peritoneal dialysis and 2-4 bags of glucose
peritoneal dialysis fluid daily for 6 months (the amount of glucose peritoneal dialysis fluid
is determined based on the treatment plan at the time of screening when the patient enters
the study). The amino acid peritoneal dialysis fluid is provided by the research center, with
the following composition: amino acids (15). The glucose peritoneal dialysis fluid is also
provided by the research center, with the following composition: this product is a
compound preparation, each 1L the composition of the solution is 1000mL, alanine 0.951g,
arginine 1.071g, glycine 0.510g, histidine 0.714g, leucine 0.850g, lysine 1.020g, l-lysine
hydrochloride 0.955g, methionine 0.850g, phenylalanine 0.570g, proline 0.595g, serine
0.510g, threonine 0.646g, tryptophan 0.270g, tyrosine 0.300g, ammonia 1.393g, sodium
chloride 5.380g, Calcium chloride (CaCl2 ·2H2O) 0.184g, Magnesium chloride (Mg, CL2·
6H2O]0.051g), Sodium lactate 4.480g, Ion concentration (mmol/L): Amino acids
87.16mmol/L, Sodium 132mmol/L, Calcium 1.25mmol/L, Magnesium 0.25mmol/L,
Chlorine 105mmol/L, Lactate root 40mmol/L. The excipients of this product include
hydrochloric acid and water for injection. This product is a glucose-free peritoneal dialysis
solution, used as part of the peritoneal dialysis regimen
One part is used for the treatment of chronic kidney patients, especially suitable for
peritoneal dialysis patients with serum albumin less than 35g/L.
The composition of glucose peritoneal dialysis fluid is shown in Figure 2:


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Drug name
composition
ion concentration
osmotic
pressure
pH
capacity
C6H12O6·H2
O
NaCl
C3H5NaO3
CaCl2·
2H2O
MgCl·6
H2O
Na
Ca
Mg
chloride
lactate
Low
Calcium
Peritoneal
Dialysis
Solution(lactate-
G1.5%)
1.5g
0.538
g
0.448g
0.0183g
0.0051g
132.01
1.25
0.25
95.04
39.97
344
4.5-
6.5
2000
Low
Calcium
Peritoneal
Dialysis
Solution(lactate-
G1.5%)
2.5g
0.538
g
0.448g
0.0183g
0.0051g
132.01
1.25
0.25
95.04
39.97
395
4.5-
6.5
2000
Low
Calcium
Peritoneal
Dialysis
Solution(lactate-
G4.25%)
4.25
0.538
g
0.448g
0.0183g
0.0051g
132.01
1.25
0.25
95.04
39.97
483
4.5-
6.5
2000
Figure 2. Composition of glucose peritoneal dialysis fluid
The daily use of 1 bag of amino acid peritoneal dialysis fluid is during the nighttime
sleep period, while the daily use of 2-4 bags of glucose peritoneal dialysis fluid is during
the daytime. The total daily infusion volume, each infusion volume, dwell time, and each
excretion volume for each subject are adjusted by the researcher based on individual
patient conditions and standardized prescriptions. During treatment, subjects should
follow the researcher's guidance for daily life and dietary management, and regularly visit
the research center for follow-up and examinations. In the third and sixth months of
treatment, subjects should repeat the screening period
All evaluation items and any adverse events or serious adverse events are recorded.
The research process is shown in Table 1:
Table 1: Research process table
Evaluate projects
Screening
period/baselin
e
stage of therapy
1 month 2 months 3 months 4 months 5 months 6 months
informed consent
√
×
×
×
×
×
×
Inclusion and exclusion criteria
√
×
×
×
×
×
×
Collect demographic data
√
×
×
×
×
×
×
Symptoms (loss of appetite,
nausea, vomiting, abdominal
distension
, Infusion pain, edema, etc.)
√
√
√
√
√
√
√


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Previous illness/treatment
√
×
×
×
×
×
×
Combination therapy with
concomitant medication
√
√
√
√
√
√
√
allergic history
√
×
×
×
×
×
×
SGA
√
√
√
√
√
√
√
check-up
√
√
√
√
√
√
√
vital sign
√
√
√
√
√
√
√
Ultrafiltration volume
√
√
√
√
√
√
√
UPD
√
√
√
√
√
√
√
BMI
√
√
√
√
√
√
√
CI
√
×
×
√
×
×
√
skin-fold thickness
√
×
×
√
×
×
√
Waist circumference and grip
strength, upper arm muscle
circumference
√
×
×
√
×
×
√
Hepatitis B related antigen
antibody, hepatitis C antibody,
HIV antibody
√
×
×
×
×
×
×
Biochemistry and liver and
kidney function (including
serum albumin,
Prealbumin), glycosylated
hemoglobin
White, fasting blood sugar
√
×
×
√
×
×
√
Nt-Pro BNP
√
×
×
√
×
×
√
nPCR
√
×
×
√
×
×
√


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nPNA
√
×
×
√
×
×
√
Kt/V and Ccr
√
×
×
√
×
×
√
PET
√
×
×
√
×
×
√
adverse event
√
√
√
√
√
√
√
(1) Informed Consent: Before participants join this study, their written consent, either
from the participant themselves or their legal representative, must be obtained. The
informed consent form should include information on the purpose, design, process, risks,
benefits, rights, and obligations of the study, as well as the participant's personal
information and contact details. The informed consent form should be signed jointly by
the researcher and the participant or their legal representative. It's kept in the research files.
(2) Collect demographic data: After the subject is selected for this study, basic
information should be recorded, including name, gender,
Age, height, weight, BMI, etc. The formula for calculating BMI is: BMI= weight (kg)
/ height m2.
(3) Collect symptoms (loss of appetite, nausea, vomiting, abdominal distension,
infusion pain, edema, etc.): After the subject is enrolled in this study, detailed questions
should be asked about gastrointestinal related symptoms and edema, which should be
recorded in CRF, and attention should be paid to whether there are causes related to this
study or influencing factors.
(4) Collecting Past Medical History and Comorbidities: After a participant is enrolled
in this study, their past medical history and comorbidities should be thoroughly inquired
about. This includes all relevant internal and external medical conditions and surgical
histories, as well as any medications currently being used or planned for use, and other
treatments. The past medical history and comorbidities should be documented in the CRF,
with attention to any factors relevant to this study
Or influencing factors.
(5) Inquiry of allergy history: After the subject is selected for this study, his/her
allergy history should be inquired in detail, including allergen, allergic reaction and so on
treatment methods, etc. Allergy history should be recorded in the CRF, and pay attention
to whether there are factors or influencing factors related to this study.


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(6) The improved SGA evaluation method was used. The higher the score, the worse
the nutrition. Normal nutrition: 7 points; mild to moderate nutrition: 8-15 points; severe
malnutrition: ≥16 points.
(7) Physical Examination: After the subject is enrolled in this study, a comprehensive
physical examination should be conducted, including the head and face, skin system,
lymph nodes, eyes, ears, nose, throat, mouth, respiratory system, cardiovascular system,
abdomen, genitourinary system, musculoskeletal system, and nervous system. The results
of the physical examination should be recorded in the CRF, with attention to any
abnormalities or related issues clinical manifestation.
(8) Monitor vital signs: After the subject is enrolled in this study, their vital signs
should be monitored regularly, including blood pressure (systolic and diastolic), heart rate
(beats per minute), respiratory rate (breaths per minute), and body temperature (℃). Vital
signs should be measured in a resting state using the same equipment and methods. The
results of the vital signs should be recorded in the CRF, noting any abnormalities
abnormal or abnormal related clinical manifestations.
(9) Record urine output and ultrafiltration: After the subject is enrolled in this study,
their urine output and ultrafiltration should be regularly recorded to assess renal function
and peritoneal function. Urine output is the average of the 24-hour urine collected at home,
and the measurement of ultrafiltration at home should be taken before and after each
session of peritoneal dialysis, using the same equipment and method. The results of urine
output and ultrafiltration should be recorded and evaluated.The average value for the first
1 month is in the CRF and note any abnormal or abnormal related clinical manifestations.
(10) Measure skinfold thickness: After participants are enrolled in this study, their
triceps skinfold thickness should be measured regularly to assess their nutritional and
physical status. The measurement of skinfold thickness should be performed on the right
upper arm at the triceps area using a standard skinfold caliper. The results of the skinfold
thickness should be recorded in the CRF, noting any abnormalities or related clinical
manifestations.
(11) Measure waist circumference, grip strength, upper arm girth, and CI: After
participants are enrolled in this study, their waist circumference, grip strength, and upper
arm girth should be measured regularly
Arm muscle circumference and CI to assess their nutritional and physical status. The
waist circumference measurement should be taken at the level of the lower edge of the
diaphragm,


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And use a soft ruler. Grip strength measurement should be taken between the thumb
and index finger of the right hand, using a standard grip strength gauge. The formula for
calculating CI is: CI= waist circumference (m) / {0.109 × [body weight (kg) / height (m)
1/2}. Waist circumference, grip strength, upper arm muscle
The results of the peritoneal and CI should be recorded in the CRF, noting any
abnormalities or abnormal related clinical manifestations.
(12) Biochemical blood tests: After the subjects are enrolled in this study, regular
biochemical blood tests should be performed, including ALT (alanine transaminase), AST
(aspartate transaminase), total bilirubin, direct bilirubin, blood urea nitrogen or urea, total
protein, albumin, creatinine, blood glucose, lactate dehydrogenase, K+, Na+, Ca2+, Cl-, etc.,
to evaluate their liver function, kidney function and metabolism
Level. The results of biochemical blood tests should be recorded in the CRF and note
any abnormalities or abnormal related clinical manifestations.
(13) Detection of Nt-pro BNP: After the subjects were enrolled in this study,
screening period and treatment at 3 months and 6 months Nt-The results of the pro BNP
should be recorded in the CRF, noting any abnormalities or abnormal related clinical
manifestations.
(14) Detection of nPCR and nPNA: After the subject is enrolled in this study, his/her
nPCR and nPNA should be regularly tested to evaluate his/her protein catabolism rate and
total protein nitrogen presentation rate. The results of nPCR and nPNA should be recorded
in the CRF and noted whether there are any abnormal or abnormal related clinical
manifestations.
(15) Calculate Kt/V and Ccr: After the subject is enrolled in this study, Kt/V and Ccr
should be calculated regularly to evaluate his/her dialysis efficiency and residual renal
function. The results of Kt/V and Ccr should be recorded in the CRF, and attention should
be paid to any abnormalities or abnormal related conditions clinical manifestations.
(16) Conduct PET testing: After subjects are enrolled in this study, regular PET tests
should be conducted to evaluate their peritoneal dialysis material transport characteristics.
The PET testing method follows the standard PET (Standard PET) proposed by Twar
dowski. Measure the glucose concentration in the effluent and compare it with that in the
infused fluid to calculate the D/P ratio and the D/D0 ratio. Based on the D/P ratio and the
D/D0 ratio, subjects are categorized into four types: high transport, high average transport,
low average transport, and low transport. The results of the PET testing should be


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recorded in the CRF, noting any abnormalities or differences common associated clinical
manifestations.
(17) Adverse events: The recording time is from the start of treatment to the end of
survival follow-up, and only AE related to this study is collected,Including adverse events
of special concern.
4.2 Data collection
4.2.1 Screening period
During the screening period, the following observations were performed on patients
who met the inclusion criteria:
Informed consent: Explain the purpose, method, benefits and risks of this study to the
patient, and obtain his/her written informed consent.
Inclusion/exclusion criteria: Check whether the patient meets the inclusion and
exclusion criteria.
Past history/comorbidities/treatment: Record the patient's past history, comorbidities
and treatment.
Comprehensive Subjective Nutritional Assessment (SGA): Using the improved
method of SGA assessment in the 2010 version of The Standard Operating Procedures for
Peritoneal Dialysis, patients were comprehensively assessed for nutritional status,
including weight change, appetite change, gastrointestinal symptoms, activity ability and
complications, physical examination, etc., and patients were divided according to the
scoring results.There are three categories: normal nutrition (A), mild malnutrition (B) or
severe malnutrition (C).Physical examination: Measure the patient's height, weight, blood
pressure, heart rate, respiratory rate and other indicators, and calculate
BMI (BMI= body mass / height 2 (kg/m2)).
Blood pressure measurement: Use standardized methods and equipment to measure
the patient's systolic and diastolic blood pressure and record itaverage value.
Body weight measurement: Use an electronic scale to measure the dry weight of the
patient and record the value.
BMI Calculation: Calculate the patient's BMI based on weight and height data, and
record its value.


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CI calculation: Use the tape measure to measure the patient's waist circumference,
and calculate the patient's CI value (CI= waist circumference (m) / {0.109 × [body weight
(kg)/ height (m)] 1/2}) according to the weight and height data, and record it numeric value.
Waist circumference and grip strength measurement: Use a tape measure to measure
the patient's waist circumference and record its value. Use a grip strength gauge, according
to the standard method, the grip strength of each patient's left and right hands was
measured once and the average value was recorded.
Triceps skinfold thickness measurement: Use a skinfold thickness gauge and follow a
standardized method on the right side of the patient the triceps, the thickness of the skin
fold was measured and recorded.
Arm muscle circumference measurement: Use a tape measure to measure the
circumference of the patient's right arm, and calculate the patient's upper arm muscle
circumference (= arm circumference (cm) 0.3142 x triceps skinfold thickness (mm))
according to the data of skinfold thickness, and record it the values.
Biochemical and liver and kidney function tests: venous blood samples were
collected from patients, and serum creatinine, blood urea nitrogen, potassium, sodium,
calcium, phosphorus, magnesium, bicarbonate, total protein, albumin, globule were
measured by automatic biochemical analyzer
Indicators such as white, bilirubin, alanine transaminase, aspartate transaminase and
alkaline phosphatase were measured and their values were recorded.
Serum albumin, prealbumin: venous blood samples were collected from patients and
bromophenol green method and immunoturbidimetric method were used,
The serum albumin and prealbumin levels of patients were measured separately and
their values were recorded.
Indicators such as nPCR,nPNA, Kt/V and Ccr were measured: according to the 2010
version of the Standard Operating Procedure for Peritoneal Dialysis, the protein catabolic
rate nPCR (g/(kg · d)) and total protein nitrogen presentation rate of patients were
calculated nPNA（g/(kg ·d））、Kt/V 、Ccr（L/1.73 m2 ）。
Nt-pro BNP: According to the level of Nt-pro BNP, patients with Nt-pro BNP
<11000pg/mL did not think there was heart failure or other factors affecting the level of Nt
-pro BNP; patients with Nt-pro BNP ≥11000 pg/mL did not think there was heart failure
or other factors affecting the level of Nt-pro BNP


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The study process was closely monitored for possible factors such as heart failure or
other factors affecting Nt-pro BNP levels.
Volume of urine, ultrafiltration: based on the patient's recent 1-month home
monitoring records, record the average daily value.
PET test: Using standardized methods, patients were subjected to a peritoneal balance
test (PET), which included the infusion of 2L of 2.5% glucose peritoneal dialysis fluid for
2 hours, followed by a 4-hour stay to measure creatinine and glucose concentrations. The
infused fluid and the excreted fluid were then measured for weight, osmotic pressure,
protein content, and creatinine content. Based on the results, the patient's ultrafiltration
volume, urea nitrogen clearance rate, creatinine clearance rate, D/P creatinine ratio, and
D/D0 creatinine were calculated
The ratio, D/P urea nitrogen ratio, D/D0 urea nitrogen ratio and other indexes were
used to classify patients into high transport type (H)
There are four types: high average transport type (HA), low average transport type
(LA) or low transport type (L).
4.2.2 During treatment
During the treatment period, each participant received a regimen of 1 bag of amino
acid peritoneal dialysis and 2-4 bags of glucose peritoneal dialysis fluid daily for 6 months
(the amount of glucose peritoneal dialysis fluid was determined based on the treatment
plan at the time of screening when the patient entered the study). In the third and sixth
months of the treatment period, participants should repeat all assessments from the
screening phase and record any adverse events or serious adverse events. Monthly follow-
up evaluations were conducted during the treatment period. Observe (infusion pain,
abdominal distension), blood pressure, weight, urine volume, ultrafiltration.
5. Treatment plan
The treatment protocol of this study is as follows:
5.1 Research treatment
5.1.1 Treatment protocol
Each subject received a treatment regimen of 1 bag of amino acid peritoneal dialysis
and 2-4 bags of glucose peritoneal dialysis fluid daily for 6 months (the amount of glucose
peritoneal dialysis fluid was determined based on the treatment plan at the time of


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screening when the patient entered the study). The amino acid peritoneal dialysis fluid was
provided by the research center, with the following composition: amino acids (15). The
peritoneal dialysis fluid was also supplied by the research center, containing the following
components in each 1L solution: 1000 mL, alanine 0.951g, arginine 1.071g, glycine
0.510g, histidine 0.714g, isoleucine 0.850g, leucine 1.020g, lysine hydrochloride 0.955g,
methionine 0.850g, phenylalanine 0.570g, proline 0.595g, serine 0.510g, threonine 0.646g,
tryptophan 0.270g, tyrosine 0.300g, arginine 1.393g, sodium chloride 5.380g, calcium
chloride (CaCL2 · 2H2O) 0.184g, magnesium chloride (Mg, CL2 · 6H2O]0.051g), and
sodium lactate 4.480g, equivalent ion concentration (mmol/L): amino acid 87.16mmol/L,
sodium 132mmol/L, calcium 1.25mmol/L,
Magnesium 0.25mmol/L, chlorine 105mmol/L, lactate 40mmo/L, the excipients of
this product are hydrochloric acid and water for injection. This product is a peritoneal
dialysis solution without grape, which is used as part of the peritoneal dialysis program for
the treatment of chronic kidney patients
It is not suitable for peritoneal dialysis patients with serum albumin less than 35g/L.
The components of the glucose peritoneal dialysate are shown in Figure 2. The use of
one bag of amino acid peritoneal dialysate is scheduled during nighttime sleep, while the
use of 2-4 bags of glucose peritoneal dialysate is scheduled during daytime hours. The
total daily infusion volume, each infusion volume, each dwell time, and each effluent
volume for each participant are determined by the researchers based on the patient's
condition
Individual circumstances and standardized prescriptions are adjusted.
5.1.2 Treatment dose adjustment
During the treatment, according to the changes of the patient's ultrafiltration volume,
blood pressure, biochemical blood, nutritional status and other indicators, the researchers
can adjust the dosage and frequency of treatment appropriately to ensure the patient's
water and electrolyte balance and metabolic stability. Specifically, the adjustment
principles are as follows:
If the patient develops signs of water retention such as weight gain, edema, and
hypertension, the researcher can increase the frequency of amino acid peritoneal dialysis
or increase the concentration of glucose peritoneal dialysis to increase ultrafiltration and
reduce water Sub-daily intake.


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If the patient shows signs of water loss such as weight loss, hypotension, and
hypoglycemia, the researcher can reduce the number of times of amino acid peritoneal
dialysis fluid or reduce the concentration of glucose peritoneal dialysis fluid to reduce the
amount of ultrafiltration and increase water intake.
If the patient shows signs of elevated or decreased blood potassium, the investigator
can administer drug therapy to replenish potassium, to maintain normal blood potassium
levels.If the patient shows signs of elevated or decreased blood calcium, the investigator
can adjust the patient's calcium and vitamin D. The dosage of the drug is to maintain the
blood calcium level within the normal range.
If the patient shows a decrease in nutritional indicators such as serum albumin,
prealbumin, nPCR, and nPNA, the researcher can increase the number of times or volume
of amino acid peritoneal dialysis to provide more amino acids and energy, and give
patients appropriate nutritional support and education.
5.2 Adjuvant therapy/combined medication
During treatment, in addition to the use of amino acid peritoneal dialysis fluid and
glucose peritoneal dialysis fluid, the subjects should also
Continue with their original adjuvant therapy, including:
Nutritional support drugs: if the patient has been taking nutritional drugs before
entering the study, continue the original nutritional drug treatment,
No additional nutritional support drugs were added after entering the study.
Antihypertensive drugs: adjust the type of antihypertensive drugs according to the
patient's blood pressure level and ultrafiltration. The dose is used to keep blood pressure
within the target range.
Antianemia drugs: erythropoietin is adjusted according to the patient's hemoglobin
level and iron metabolism. The type and dose of EPO and iron supplements were used to
improve anemia.
Calcium and vitamin D drugs: according to the patient's blood calcium, blood
phosphorus, parathyroid hormone (PTH) and other indicators
Targets, adjust the types and doses of calcium and vitamin D drugs to prevent and
treat renal bone disease.


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Phosphorus binder: Adjust the type and dose of phosphorus binder according to the
patient's blood phosphorus level and diet. Control blood phosphorus levels within the
target range.
Anticoagulant drugs: adjust the type and dose of anticoagulant drugs according to the
patient's coagulation function to prevent and treat thrombosis.
Other drugs: other necessary drug therapy, such as anti-infective drugs, is given
according to the specific condition of the patient anti-heart failure drugs, anti-arrhythmia
drugs, uric acid reduction.
5.3 Treatment compliance
During the treatment period, participants should use the amino acid peritoneal
dialysate and glucose peritoneal dialysate correctly according to the instructions and
prescriptions of the researcher, and record each infusion volume, retention time, and
output. Participants should submit their daily treatment logs to the researcher for
verification and storage. Participants should maintain good peritoneal dialysis techniques
and hygiene habits to prevent infections and complications. Participants should regularly
visit the research center for follow-up visits and examinations, and promptly report any
adverse reactions or discomforts to the researcher. Participants should adhere to dietary,
hydration, and exercise recommendations provided by the researcher and avoid using
other drugs or treatments that may affect the results of this study. If a participant is unable
to continue participating in this study for any reason, they should notify the researcher in a
timely manner and explain the reasons for withdrawal follow.
6. Adverse events
6.1 Definition of adverse events
Adverse events (Adverse Event, AE) are any harmful medical events that occur
during a clinical trial. Events, regardless of whether they have a causal relationship with
the test drug. Adverse events include the following: Adverse reactions related to the test
drug (Adverse Reaction, AR): refers to the normal use conditions. Any harmful medical
event caused by the pharmacological action of the test drug or for other reasons. Adverse
events not related to the test drug: any harmful medical event that occurs during a clinical


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trial, However, it was scientifically determined that there was no causal relationship with
the test drug.
Serious adverse events (Serious Adverse Event, SAE): refers to those that occur
during clinical trials
Any harmful medical event, regardless of whether it has a causal relationship with the
investigational drug, that results in one of the following outcomes:
Causing death;
Life-threatening (i.e., potentially fatal if not promptly intervened);
Hospitalization or extension of hospitalization is required;
Causing permanent or significant disability or impairment;
Causing congenital malformations or birth defects;
Major medical intervention (such as surgery, blood transfusion, etc.) is required.
6.2 Observation and handling of adverse events
In this study, all subjects should undergo regular safety assessments, including
subjective patient reports (such as abdominal pain, bloating), blood pressure, ultrafiltration
volume, urine output, Nt-pro BNP, Kt/V, Ccr, PET, and other indicators. Researchers
should document all adverse events that occur during the clinical trial and observe and
manage them. The principles of inspection and handling are as follows:
The investigator should ask the subject if he or she feels any discomfort and actively
observe whether the subject has any abnormal symptoms present.
Researchers should record the name, time of occurrence, duration, severity, and trial
of all adverse events information such as causality, treatment measures and outcomes of
the drug should be filled in the adverse event report form.
Researchers should provide appropriate treatment and support measures according to
the nature and severity of adverse events closely monitor the subject's condition.
Researchers should decide whether to continue use based on the causal relationship
and impact of adverse events and trial drugs.The test drug or withdrawal from the study.
Researchers should report all adverse events that occur during clinical trials to the
ethics committee and sponsor in a timely manner events and track and update them as
required.


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6.3 Criteria for judging the relationship between adverse events and
tests
The causal relationship between adverse events and the test drug should be judged
according to the following criteria:
Assured of relevance (Definitely Related): Adverse events are related to the
pharmacological action of the investigational drug or a known adverse event
The results were consistent and other possible causes were ruled out.
Most likely related (Probably Related): Adverse event and pharmacological action of
the investigational drug or known no The good response is consistent and other possible
causes are unlikely.
May be related (Possibly Related): Adverse event is related to the pharmacological
action of the investigational drug or a known adverse eventThere are some similarities in
the reaction, but there are other possible reasons.
It is unlikely to be related (Unlikely Related): the adverse event is related to the
pharmacological action of the investigational drug or is known. There was no clear
similarity in the adverse reactions and there were other more likely causes.
Irrelevant (Not Related): The adverse event is completely unrelated to the
pharmacological action of the test drug or a known adverse reaction. It does not match and
there are other clear reasons.
6.4 Evaluation of adverse reactions
Adverse reactions (i.e., adverse events related to the investigational drug) should be
evaluated according to the following criteria:
Mild (Mild): The adverse reaction is mild and does not affect the daily life and work
of the subject, and no special treatment is required texture.
Moderate (Moderate): Moderate adverse reactions, affecting the daily life and work
of subjects, requiring certain therapeutic or supportive measures.
Severe (Severe): The adverse reaction is serious and seriously affects the daily life
and work of the subject, requiring urgent treatment rapid or specialized treatment or
support measures.


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6.5 Reporting of adverse events
All adverse events occurring during clinical trials shall be reported in accordance
with the following requirements:
All adverse events should be filled in the adverse event report form within 24 hours
after occurrence and 7 days after occurrence and report to the ethics committee and
sponsor within days. All serious adverse events should be reported by telephone, fax,
email, etc. within 24 hours after occurrence. Notify the ethics committee and the sponsor,
and submit a written report within 7 days after the occurrence. All serious unexpected
reactions (Serious Unexpected Adverse Reaction, SUSAR) related to the test drug should
be reported to the National Food within 24 hours of occurrence by telephone, fax, email,
etc. The drug administration shall submit a written report within 15 days after the
occurrence. All serious unexpected adverse reactions unrelated to the test drug should be
reported by telephone, fax or electronic means within 7 days of occurrence. Report to the
State Food and Drug Administration by mail, etc., and submit a written report within 30
days after the occurrence.
7. Statistical considerations
7.1 Sample size calculation
This study is a post-marketing study, and a total of 140 subjects are planned to be
included. The efficacy evaluation standard is 6 months of treatment
If the difference between the post-relative baseline change of Δ serum albumin or Δ
prealbumin is statistically significant, it is considered
The treatment was effective. Based on the above hypothesis, a single sample self-
preceding and following control design and a unilateral difference test were used
Quantity estimation formula:
（za + zβ ) σ2
n
=
δ2
δ is the difference; σ is the standard deviation, which will be replaced by the sample
size standard deviation.
2


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The Hochberg method was considered to adjust for multiple endpoints, with the
smallest test level α/2= 0.0125 (one-sided) and power (1- β) = 0.9, based on the sample
size estimates for different primary efficacy endpoints
count.
1) Based on Δ serum albumin: According to the literature, it is assumed that the
baseline serum albumin before treatment is 27 g/L, and the serum albumin after 6 months
of amino acid peritoneal dialysis treatment is 28.5g/L, δ is 1.5g/L, and the standard
deviation is 4.5 g/L,
The required sample size for the calculation was 112.
2) Based on Δ prealbumin: According to the literature, it is assumed that the baseline
prealbumin before treatment is 240 mg/L, the prealbumin 6 months after amino acid
peritoneal dialysis treatment is 300mg/L, δ is 60mg/L, and the standard deviation is 80
mg/L, the required sample size for calculation is 23 cases.
In order to ensure that the final analysis of this study has enough sample size,
considering the possible loss to follow-up, withdrawal, invalid data and other situations,
the maximum sample size of 112 cases estimated based on the above two indicators will
be increased by 20%
The dropout rate was expanded to a total sample of 140 cases.
7.2 analysis set
Full analysis set (Full Analysis Set, FAS): All subjects who received at least one
study treatment.This analysis set will be used primarily for baseline data analysis.Safety
Analysis Set (Safety Analysis Set, SS): Received at least one study treatment and was on
medication. All subjects in the safety record. This data set will be used primarily for safety
analysis.Effectiveness Analysis Set (Effectiveness Analysis Set, EAS): All subjects
included received at least one study treatment and had valid evaluation data at at least one
post-treatment observation time point. The analysis set will be used mainly for efficacy
analysis.
7.3 stochastic
This study adopted the self-control design, that is, each subject first used
conventional peritoneal dialysis fluid for 3 months. And the patients were given 6 months
of intravenous albumin peritoneal dialysis. Therefore, randomization was not required for
this study. Subjects were screened enrollment in the order of success.


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7.4 General analysis considerations
Continuous variables will be statistically described based on the data distribution,
including number of cases (non-missing numbers), mean, standard deviation, median and
quartiles, maximum value, and minimum value. For categorical variables, the number of
cases and percentages for each category will be calculated unless otherwise specified;
missing cases will not be included in percentage calculations, and counts with zero cases
will be displayed as "0". The distribution of participants, demographic characteristics, past
medical history/comorbidities/treatment, and study endpoints will be provided statistical
analysis summary.
7.5 Missing data
For participants enrolled in the study, researchers will make every effort to collect
their data, especially data related to the primary endpoint. If a participant's efficacy data
is missing for any reason, continuous variables will be handled using the last observation
carry-forward method (Last Observation Carried Forward, LOCF), while categorical
data will be processed according to actual circumstances or filled in through modeling.
Missing data.Other processing methods are described in detail in the Statistical Analysis
Plan (SAP).
7.6 Statistical analysis methods
7.6.1 Demographic and baseline status, compliance, medical history, and
analysis of concomitant disease treatment
Descriptive statistics of demographic and baseline characteristics of enrolled subjects
will be performed based on the FAS set.The demographic data and baseline characteristics
of all subjects were listed.Descriptive statistics were performed for treatment compliance
throughout the study period, and compliance levels were summarized (i.e., <80% Number
and percentage of subjects (80% to 120% and>120%). Summarize the number and
percentage of subjects with a history of disease and comorbidities/treatment categories.


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7.6.2 Statistical analysis of the primary endpoint
Statistical analysis of the primary endpoint will be based on the EAS set, including
primary analysis and sensitivity analysis.
1) Main analysis:
1) Descriptive analysis will be used to summarize the baseline, post-treatment 6
months albumin and pre-protein measurements of the subjects in the group, as well as the
difference in change from baseline; LOCF will be used to process the data on major
efficacy loss
The paired t-test was used to test the difference before and after treatment.
2) Sensitivity analysis: The robustness of the analysis results will be evaluated by
considering different missing data processing situations. The missing data of the main
efficacy after treatment will be filled with the mean and median of the complete
observation data respectively method, hypothesis testing is the same as the main analysis.
7.6.3 Statistical analysis of secondary endpoints
Based on the EAS dataset, descriptive analysis will be used to summarize the
baseline characteristics of enrolled subjects, changes in nutritional status, metabolic state,
residual renal function, and trends in dialysis adequacy at 3 months and 6 months post-
treatment, with graphical presentations. For the comparison of changes from baseline:
continuous variables will be compared using paired t-tests or Wilcoxon-signed rank tests
based on data distribution; for categorical variables, McNemar-tests will be used compare
yourself before and after.
7.6.4 safety analysis
Based on the SS set, all AE will be summarized by descriptive analysis. In addition,
they will be summarized separately by drug correlation, drug-related treatment measures,
outcomes and severity. If necessary, they will be summarized by subgroup (e.g
Data were stratified according to whether dialysis was adequate or heart failure).
Summarize the changes of vital signs, laboratory tests and ECG results of each group
relative to baseline, the results with clinical significance after baseline and all test results
were listed.


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7.6.5 Exploratory analysis
Patients were divided into adequate and inadequate groups according to baseline
Kt/V ≥1.7, and the improvement of nutritional indicators in different subgroups was
studied
Analysis of variance. If applicable, differences in the improvement of nutritional
indicators will be tested based on different groups of baseline.
7.7 Multiplicity issues
This study involves multiple primary efficacy endpoints: Δserum albumin and
Δprealbumin. If any one of these endpoint indicators is statistically significant, the trial is
considered effective, which can lead to an inflated overall false discovery rate (FWER).
The Hochberg method is planned to control FWER: the P-values of the two tests are
ranked from largest to smallest, denoted as p(1)> p(2), and then compared with the
corresponding ai in descending order. First, the hypothesis H(01) corresponding to the
largest r-value p(1) is tested. If p(1) <a1 (a1 = a, one-sided 0.025), all null hypotheses are
rejected, and the test is stopped; if the one-sided test p(1) ≥0.025, H(01) is not rejected,
and the next test continues; the test level a2 = (one-sided 0.0125) continues to test H(02).
Statistical tests for other indicators are not the primary objective and are not considered
multiple adjustments.
8.Ethical norms
The ethical guidelines for this study are as follows:
8.1 Ethical review
This study must be reviewed and approved by the ethics committees of each center
before it officially begins, and must comply with relevant laws, regulations, and guidelines
such as the World Medical Association's Helsinki Declaration and the National Medical
Products Administration's Quality Management Standards for Clinical Trials. All
documents and materials of this study, including the trial protocol, informed consent form,
drug instructions, adverse event report forms, etc., should be submitted to the ethics
committee for review. If any significant changes or unexpected events occur during the


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study, they should be promptly reported to the ethics committee, and reapply for review
and approval.
8.2 Informed consent
This study must provide participants with a detailed informed consent form before
recruitment. The researcher or their authorized personnel should explain the purpose,
methods, duration, benefits, risks, rights, obligations, confidentiality, and withdrawal
procedures of the study to the participants both orally and in writing, and answer any
questions or concerns raised by the participants. Participants must sign the informed
consent form after fully understanding and voluntarily agreeing to participate, with a copy
retained. The informed consent form should be written in the language and cultural
context of the participants, using simple and clear language as much as possible. If the
participant is a minor or unable to sign the informed consent form, it should be signed by
their legal guardian or authorized representative the person in charge shall sign on behalf
of the subject and obtain the consent of the subject himself.
8.3 Protection of subjects' rights and interests
In this study, the following principles should be observed in protecting the rights and
interests of subjects:
Respect the autonomy of the subject: The subject has the right to choose whether or
not to participate in this study and when to withdraw from this study without any coercion
or influence. After withdrawing from this study, the subject still has the right to receive
appropriate medical care and care bosom.
Protection of the welfare of subjects: Subjects have the right to benefit from this
study, including improving their health status, improving their quality of life, and
acquiring new medical knowledge. Subjects also have the right to benefit from this study
compensation for damages, including medical expenses, transportation expenses, loss of
earnings, etc.
Maintain the dignity of the subject: The subject has the right to keep his or her
personal information and medical data confidential and not disclosed
Disclosure or abuse. Participants also have the right to avoid any discrimination or
humiliation arising from their participation in this study.


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8.4 Data quality and security supervision
In order to ensure data quality and security, the following principles should be
observed in this study:
Ensure the authenticity of data: Researchers should collect, record, verify, store, and
report all research data accurately, completely, and promptly according to the trial protocol
and operating procedures. There must be no falsification, omission, alteration, or
concealment. Researchers should use a standardized data entry form and fill it out with a
black ink pen. If corrections are needed, a line should be drawn through the original
content, followed by a signature and date. The use of correction fluid or similar substances
is strictly prohibited correction bands, etc.
Ensure the validity of data: Researchers should regularly conduct quality control and
assurance for research data, checking the integrity, consistency, accuracy, and reliability of
the data, and promptly correcting or supplementing any errors or missing data.
Researchers should accept data monitoring and auditing from sponsors or their authorized
institutions, and cooperate in providing all necessary information for the study relevant
documents and information, and accept their verification and validation of the data.
Ensure data security: Researchers should properly manage all research data to
prevent loss, damage, leakage, or misuse. They should protect electronic data using
passwords or encryption methods and back it up regularly. Researchers should archive and
preserve paper data according to legal requirements and the ethics committee's guidelines
limit their access.
9. Quality assurance
The quality assurance of this study is as follows:
9.1 Requirements for project leader
The project leader should have relevant knowledge and experience in clinical
research and be able to effectively organize and manage the study all aspects of the
research to ensure the scientific, compliance and quality of the research.
The project leader shall be responsible for the formulation and revision of the test
plan and provide detailed instructions to the researchers in each center. Provide
standardization and training guidance to ensure the uniformity and standardization of this
study. The project leader shall be responsible for effective communication with the


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sponsor, ethics committee, supervisory agency and statistical agency, report the progress
and results of this study in a timely manner, and deal with any problems and risks that may
arise.The project leader shall be responsible for supervising the researchers of each center
to comply with the trial protocol and ethical norms, regularly reviewing and providing
feedback on the data of each center, and recording and correcting any violation or
deviation from the trial protocol the first month of the lunar year.The project leader shall
be responsible for the preservation of all documents and materials of the study, and
summarize and conclude after the completion of the study appraise.
9.2 Requirements for researchers
Researchers should have relevant knowledge and experience in clinical research, and
be able to follow the trial protocol and operating specifications. To carry out all tasks of
this study in a correct, complete and timely manner to ensure the reliability and
effectiveness of this study. Researchers shall sign a training confirmation after receiving
training from the project leader or his authorized agency and obtain it After approval by
the ethics committee, subjects were recruited and the study was conducted.
Researchers should provide a detailed informed consent form to the subject before
recruiting the subject, which shall be signed by the subject and a copy shall be kept.
Researchers should respect the autonomy, welfare and dignity of the subject and protect
the subject confidentiality of personal information and medical data.
Researchers should use a standardized data collection form (CRF) and fill it out with
a black ink pen. If corrections are needed, a line should be drawn over the original content,
and a signature along with the date should be noted; no correction fluid or correction tape
should be used. Researchers should regularly send the CRF to the project leader or their
authorized institution and keep a copy on file stem or root of plants.
Researchers should follow up and evaluate subjects regularly according to the
protocol, and record all events and outcomes related to the study. Researchers should
report any adverse events or serious adverse events in a timely manner, and root
according to the instructions of the project leader or its authorized agency, carry out
corresponding processing and tracking.
Researchers shall comply with the supervision and audit of the project leader or its
authorized agency, and cooperate in providing all relevant research review relevant
documents and data, and accept their verification of the data.At the end of this study, the
researchers should submit all CRF, informed consent form, adverse event report form and


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other documents and data shall be archived and preserved, and summarized and evaluated
according to the requirements of the project leader or its authorized agency.
9.3 Quality control of treatment plan formulation and
implementation
The treatment plan shall be formulated by the project leader or its authorized agency,
and shall be submitted to the trial protocol and operating specifications. Researchers at
each
center
provide
detailed
guidance
and
training
to
ensure
uniformity
and
standardization of treatment plans. The treatment plan should include the name,
specification, dosage, frequency, route and duration of the treatment drugs. Make
appropriate adjustments and optimizations according to the specific conditions of the
subjects. The therapeutic drugs shall be provided by the sponsor or its authorized agency
and stored in accordance with the prescribed conditions and methods. Storage, transport,
distribution, use and recovery to ensure the quality and safety of therapeutic drugs. The
use of therapeutic drugs should be carried out by the investigator or his authorized
personnel in accordance with the treatment plan and operating specifications, record,
verify, monitor and evaluate, and report in a timely manner any events and outcomes
related to the treatment drugs.
10. Data processing and data preservation
10.1 Case Report Form (CRF)
The Case Report Form (CRF) is a standardized table that records all data and
information of the subject throughout the study process. The CRF should be promptly,
accurately, and completely filled out by the investigator or their authorized personnel after
each visit or observation, with the date signed. The CRF should be designed and compiled
according to the observation items and time points specified in the trial protocol, including
baseline data, follow-up data, efficacy evaluation, safety evaluation, adverse event records,
etc.
The CRF should follow the following principles:
The CRF should be filled out in Chinese or English. If other languages are required
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The translation shall be verified and signed by the researcher or his authorized
personnel.
The CRF should be filled out with a black ink pen or signature pen and not with a
pencil or any other colored pen.
The CRF should be clear, neat and easy to identify. There should be no alteration,
cancellation or covering. If there is any error or omission, a horizontal line should be
drawn on the original data and the correct data should be written next to it, and the person
who filled in the form should write it date of signature. Do not use correction fluid or
correction tape to modify the data.
The CRF shall reflect the authenticity and integrity of the original data, and no data
shall be added, deleted or modified at will. If there is any data, any change or supplement
shall be explained and signed by the investigator or his authorized person with the
date.The CRF should be filled in in time according to the time point specified in the trial
protocol, and should not be delayed or filled in in advance. If the data are delayed or
missing due to special circumstances, the reason should be explained and signed by the
investigator or his authorized person on the date.The CRF should be filled out by the
investigator or his authorized person in person and should not be entrusted to others. If
more than one person is involved in filling out the CRF. Write, indicate your name and
responsibilities on the CRF, and sign the date of responsibility in each section.The CRF
should be stored in a safe, dry and fireproof place after each filling, and should not be lost
or damaged. If there is an electronic version of the CRF, appropriate measures should be
taken to protect the security and confidentiality of the data, so as to prevent the data from
being tampered with or leaked reveal.
10.2 Establishment of databases
In order to ensure the quality and reliability of the data, a special database system will
be established for CRF data entry, verification, analysis and management. The database
system should have the following functions:
The database system should have a reasonable structure and standard format, can
effectively store, retrieve and process data occupy. The database system should have a
good user interface and operation guide, can easily enter data, repair modify, query and
export. The database system should have strict permission control and authentication
mechanism, only authorized users are allowed to access and operate data and record user
operation logs. The database system should have effective data verification and quality


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control functions, can detect and correct the data errors, anomalies and inconsistencies are
generated and corresponding reports and alerts are generated. The database system should
have perfect data backup and recovery functions, and can prepare data regularly or at any
time. In addition, data loss or damage can be recovered in time. The database system
should have flexible data analysis and reporting functions, which can be based on research
objectives and statistical methods, perform descriptive and inferential analysis of the data
and generate corresponding tables and graphs.
The establishment and maintenance of the database system is the responsibility of
professional data managers, whose main work includes: Design and establish the database
system according to the test plan and CRF content, and conduct testing and verification.
Enter, check, verify and clean the data in CRF to ensure the accuracy and integrity of the
data. Perform regular or irregular maintenance and update of the database system to
ensure the security and stability of data. Provide data query, export, analysis and reporting
services at the request of researchers or monitors. After the study is completed, the
database system shall be sealed and relevant documents and records shall be kept.
10.3 Preservation of information
All data involved in this study, including CRF, database, raw data, analysis data,
statistical report, informed consent, ethics approval, trial protocol, trial drug records, etc.,
shall be in accordance with national laws and regulations
The principle of proper preservation and management shall be followed. The
preservation of the data shall follow the following principles:
The data should be kept in a safe, dry and fireproof place to prevent loss or damage.
If there is electronic data, appropriate measures should be taken to protect the security and
confidentiality of the data and prevent the data from being tampered with or leaked. The
data shall be kept for no less than 15 years according to the prescribed time limit. If there
are special circumstances, the period may be extended or shortened. The retention period
should be approved by the ethics committee and justified. The data shall only be consulted
or used by authorized personnel, and the time, purpose and results of consultation or use
shall be recorded. If the data need to be provided to a third party, the consent of the subject,
the investigator, the sponsor and the ethics committee shall be obtained,
And sign the corresponding agreement.At the end of the retention period, the data
shall be destroyed or transferred in accordance with the prescribed procedures. If the data


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is to be destroyed, it shall be ensured that the data is completely destroyed and cannot be
recovered or identified. If the data is to be transferred, it shall be ensured that the data is
intact transfer, and the receiving party shall bear the responsibility of preservation and
management.
11. Clinical research sponsor
Peritoneal dialysis Center, Gaozhou People's Hospital.
12. Work progress
The progress of the study is shown in Table 2 below:
Table 2. Work schedule
job content
leading official
start time
terminal time
remarks
Design and revision of the test
plan
investigator
April 1, 2023
September
30,2023
-
and approval of the ethics
committee
investigator
October 1, 2023
October 30,2023
-
Application and procurement of
test drugs
investigator
October 1, 2023
October 30,2023
-
nd production of case report form
(CRF)
ata management
personnel
April 1, 2023
September
30,2023
-
Training and assessment of
researchers
investigator
September 30,2023
October 30,2023
-
Screening and enrollment of
subjects
investigator
November 01,2023
April 30,2024
-
Treatment and follow-up of
subjects
investigator
November 01,2023
October 30,2024
-
Collection and verification of CRFata management
personnel
October 30,2024
November
30,2024
-
Data entry and cleaning
ata management
personnel
November 30,2024
December 30,2024-
Data analysis and reporting
data management
Personnel/research
The investigator
January 1, 2025
January 30,2025
-
Publication and dissemination of
research results
investigator
February 1, 2025
-
-


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Preservation and destruction of
data
investigator /
data management
personnel
-
-
Press
illuminate
instrument
for drawing
circles
Fix defend
Exist 15year
References
[1] Sun Bin, Li Xueqin, Ma Qiang. The influence of amino acid peritoneal dialysis on the
dialysis efficacy and nutritional status of peritoneal dialysis patients[J]. Chinese
Medical Journal, 2019, 21(1): 21-24.
[2] Wang Jun, Yu Yusheng, Jia Zhonghui, et al. The effect of amino acid peritoneal dialysis
on the nutritional status of peritoneal dialysis patients[J]. Journal of Kidney Disease
and Dialysis, 2004, 13(4): 330-335.
[3] Sun Yuling, SUSAN YUNG, Yu Xueqing, et al. Effects of amino acid peritoneal
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