A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status in Peritoneal Dialysis Patients
Phase: PHASE4
Conditions: End-stage Renal Disease (ESRD), Peritoneal Dialysis (PD), Nutritional Status, Renal Replacement Therapy
Sponsor: Shanghai 10th People's Hospital

Study Protocol with Informed Consent Form 
Title: A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on 
the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving 
Nutritional Status of Peritoneal Dialysis Patients 
Version No.: 1.0 
Version Date: December 10, 2025 
IRB Approval No.: SHSY-IEC-6.0/26K8/P01 
IRB Approval Date: January 9, 2026 
Sponsor: Shanghai Tenth People’s Hospital 
Principal Investigators: Xue Wen 
Department: Department of Nephrology 
1. Study Objectives 
1.1 Primary Objective 
To evaluate the efficacy of Amino Acid (15) Peritoneal Dialysis Solution in 
improving the nutritional status of patients receiving peritoneal dialysis. 
1.2 Secondary Objectives 
• 
Observe the effects of the solution on dialysis adequacy and peritoneal 
transport function. 
• 
Monitor adverse events and complications to assess the short-term safety of 
the solution. 
1.3 Exploratory Objective 
To explore the mechanism by which Amino Acid (15) Peritoneal Dialysis Solution 
improves nutritional status in peritoneal dialysis patients through intra-abdominal 
amino acid supplementation. 
2. Study Design 
• 
Study Type: Interventional clinical study 
• 
Design: Single-center, prospective, open-label, self-controlled (before-and-
after comparison) 

• 
Total Study Duration: 24 months (from study initiation to final report 
completion) 
• 
Intervention Period per Participant: 6 months (starting on the enrollment 
day) 
• 
Sample Size: 50 participants 
3. Study Population 
3.1 Inclusion Criteria 
• 
Aged ≥ 18 years. 
• 
Receiving peritoneal dialysis for ≥ 6 months. 
• 
Serum albumin level < 38 g/L. 
• 
No history of peritonitis in the past 3 months and no hospitalization in the past 
1 month. 
• 
No severe heart, liver, or other organ dysfunction, or malignant tumors. 
• 
Expected survival time > 1 year. 
• 
Good compliance and willingness to sign the informed consent form. 
• 
Diagnosed with end-stage renal disease (ESRD) with estimated glomerular 
filtration rate (eGFR) < 15 mL/ (min·1.73 m²). 
3.2 Exclusion Criteria 
• 
Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or 
any of its components. 
• 
Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal). 
• 
Taking medications that affect protein metabolism and unable to maintain a 
stable dose during the study. 
• 
Need for adjustment of nutritional supplement doses during the study. 
• 
Uncorrectable severe gastrointestinal reactions. 
• 
Pregnant, lactating, or planning to undergo kidney transplantation. 
3.3 Withdrawal/Termination Criteria 
3.3.1 Participant Withdrawal 
• 
Failure to undergo dialysis as per protocol for 3 consecutive days. 
• 
Two consecutive missed follow-up visits. 

• 
Voluntary withdrawal by the participant. 
• 
Intervention duration < 3 months. 
3.3.2 Participant Exclusion 
• 
Missing data > 10% of required outcome measures. 
• 
Severe violation of the study protocol. 
3.3.3 Early Study Termination 
• 
Incidence of serious adverse events (SAEs) > 10%. 
• 
No clinically meaningful differences in the primary outcome measure 
identified by the Data Monitoring Committee. 
• 
Uncontrollable study bias or operational difficulties. 
4. Intervention Measures 
4.1 Intervention Product 
Amino Acid (15) Peritoneal Dialysis Solution (2 L/bag, manufactured by Shandong 
Weigao Group). 
4.2 Administration Protocol 
• 
Participants maintain their original peritoneal dialysis regimen throughout the 
study. 
• 
Replace one bag of conventional glucose-based dialysis solution with Amino 
Acid (15) Peritoneal Dialysis Solution after lunch, once daily. 
• 
Continuous intervention for 6 months per participant. 
• 
Dose adjustment: The 2 L/dose is maintained unless safety issues arise (e.g., 
severe metabolic acidosis), which will be managed with oral sodium 
bicarbonate as clinically indicated. 
4.3 Concomitant Medications 
• 
Participants must maintain stable doses of medications affecting protein 
metabolism and nutritional supplements throughout the study period. 
• 
Any necessary dose adjustments due to severe clinical complications (e.g., 
severe infection) will result in participant withdrawal, with follow-up until 
symptoms stabilize. 
5. Outcome Measures 

5.1 Primary Outcome Measure 
Serum albumin (Alb) level: Measured at baseline (enrollment day), 3 months, and 6 
months post-intervention. 
5.2 Secondary Outcome Measures 
Category 
Indicators 
Assessment 
Time Points 
Nutritional 
Status 
Prealbumin (PA), Subjective Global Assessment 
(SGA) score, Transferrin (TF), Lean Body Mass 
(LBM), Grip strength, Mid-Arm Muscle 
Circumference (MAMC), Blood amino acid profile 
Baseline, 6 
months post-
intervention 
Dialysis 
Adequacy 
Total Kt/Vurea, Peritoneal Creatinine Clearance 
(Ccr) 
Baseline, 6 
months post-
intervention 
Peritoneal 
Transport 
Function 
Creatinine Mass Transfer Area Coefficient 
(MTACcr), Dialysate Urea-Creatinine Ratio (R-
Ccr) 
Baseline, 6 
months post-
intervention 
Dialysis-
Related 
Ultrafiltration Volume (UF) 
Every 2 weeks 
during 
intervention 
5.3 Safety Outcome Measures 
• 
Adverse events (AEs): Including peritonitis, gastrointestinal reactions (e.g., 
abdominal distension, diarrhea), metabolic acidosis, etc.; recorded throughout 
the study period. 
• 
Serious adverse events (SAEs): Including death, life-threatening events, 
prolonged hospitalization, permanent disability, etc.; reported to the Ethics 
Committee and sponsor within 24 hours of identification. 
6. Study Procedures 
6.1 Timeline 

Phase 
Duration 
Key Activities 
Preparation & 
Rolling 
Recruitment 
January 2026 – 
June 2027 (18 
months) 
Screen participants, verify eligibility, obtain 
informed consent, complete baseline 
assessments (recruitment continues until 6 
months before study end to ensure all 
participants finish 6-month follow-up) 
Intervention & 
Follow-up (Per 
Participant) 
6 Months Post-
Enrollment 
Implement intervention, conduct biweekly 
follow-up (record UF and AEs), perform 3-
month serum albumin testing 
Final Post-
Intervention & 
Study Closure 
July 2027 – 
December 31, 
2027 (6 months) 
Complete 6-month outcome assessments for the 
last enrolled participants; finalize data 
verification, statistical analysis, and study 
report writing 
6.2 Specific Procedures 
1. Baseline Assessment (Enrollment Day): Collect demographic data, perform 
physical examination, conduct laboratory tests (blood, urine, dialysate 
samples), evaluate peritoneal function, complete SGA scoring, and measure 
muscle mass. 
2. Intervention Period: Conduct biweekly follow-up to record UF volume, AEs 
and assess medication compliance. Perform serum Alb testing and AE review 
at the 3-month follow-up. 
3. 6-Month Post-Intervention: Repeat all baseline assessments to measure 
outcome indicators. 
4. Withdrawal Visit: Complete safety assessments and data supplementation for 
participants who withdraw from the study. 
7. Statistical Analysis Plan 
7.1 Statistical Software 
SPSS 26.0 
7.2 Data Analysis Principles 

• 
Intention-to-Treat (ITT) Analysis: All enrolled participants will be included 
in the ITT set, regardless of protocol adherence. 
• 
Per-Protocol (PP) Analysis: Participants who complete the full intervention 
and have no major protocol violations will be included in the PP set for 
sensitivity analysis. 
7.3 Descriptive Statistics 
• 
Continuous data: Presented as mean ± standard deviation (SD) if normally 
distributed, or median (interquartile range [IQR]) if non-normally distributed. 
• 
Categorical data: Presented as counts (percentages). 
7.4 Inferential Statistics 
• 
Primary Outcome: Compare serum Alb levels before and after intervention 
using paired t-tests (if normally distributed) or Wilcoxon signed-rank tests (if 
non-normally distributed). 
• 
Secondary Outcomes: Use the same statistical methods as the primary 
outcome for continuous indicators; use Chi-square tests or Fisher’s exact tests 
for categorical safety indicators. 
• 
Correlation Analysis: Use Pearson or Spearman correlation tests to explore 
associations between nutritional indicators and other outcomes. 
• 
Significance Level: Two-tailed α = 0.05. 
7.5 Sample Size Justification 
Based on a pre-study pilot (n=20), the standard deviation (σd) of serum Alb changes 
is 4 g/L, and the clinically meaningful difference (δ) is 3 g/L. With a two-tailed 
α=0.05 and power=80%, the minimum sample size is 14. Accounting for a 15% 
withdrawal rate, 50 participants are enrolled to ensure result robustness. 
7.6 Missing Data Handling 
Missing data will be addressed using multiple imputation methods to minimize bias in 
the analysis results. 
8. Data Management & Quality Control 

• 
Data Collection: Use Electronic Case Report Forms (eCRFs) combined with 
paper records; anonymize data using unique study IDs to protect participant 
privacy. 
• 
Data Verification: Implement double data entry, with all modifications 
tracked and documented in the audit trail. 
• 
Equipment Calibration: Calibrate testing instruments every 3 months to 
ensure measurement accuracy. 
• 
Personnel Training: Provide uniform training on study protocols and 
Standard Operating Procedures (SOPs) to all study personnel before study 
initiation. 
• 
Metadata Removal: Redact and remove metadata from all electronic 
documents before submission to ensure compliance with data privacy 
regulations. 
9. Ethics & Compliance 
• 
The study complies with the 2024 Declaration of Helsinki, Good Clinical 
Practice (GCP), and relevant national regulations. 
• 
Approved by the Ethics Committee of Shanghai Tenth People’s Hospital 
(Approval No.: SHSY-IEC-6.0/26K8/P01; Approval Date: January 9, 2026). 
• 
Informed consent will be obtained from all participants (or legal 
representatives) before enrollment. 
• 
All personally identifiable information (PII) and confidential commercial 
information will be redacted before any public disclosure. 
 
Informed Consent Form 
Study Title: A Single-Center, Prospective, Open-Label, Self-Controlled Clinical 
Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in 
Improving Nutritional Status of Peritoneal Dialysis Patients 
Version No.: 1.0 
Version Date: December 10, 2025 

IRB Approval No.: SHSY-IEC-6.0/26K8/P01 
IRB Approval Date: January 9, 2026 
Introduction 
You are invited to participate in a single-center clinical study conducted by the 
Department of Nephrology, Shanghai Tenth People’s Hospital. This study has been 
approved by the hospital’s Ethics Committee. It is important that you understand the 
study’s purpose, procedures, benefits, and risks before deciding to participate. Please 
read this form carefully, and feel free to discuss it with your family or ask the 
researchers any questions you may have. 
1. Study Purpose 
This study aims to evaluate whether Amino Acid (15) Peritoneal Dialysis Solution 
can improve the nutritional status of patients receiving peritoneal dialysis. It will also 
observe the solution’s effects on dialysis adequacy and peritoneal transport function, 
and monitor its short-term safety. Additionally, blood, urine, and dialysate samples 
will be collected for related research purposes. 
2. Study Procedures 
If you meet the eligibility criteria and agree to participate: 
1. Baseline Assessment: On the enrollment day, you will undergo physical 
examinations, laboratory tests, and nutritional status evaluations. 
2. Intervention: You will continue your regular peritoneal dialysis regimen, 
replacing one bag of dialysis solutions with Amino Acid (15) Peritoneal 
Dialysis Solution (2 L/bag) after lunch, once daily, for 6 months. 
3. Follow-up: You will need to attend follow-up visits at the hospital on the 
enrollment day (baseline), 3 months, and 6 months post-intervention. 
Biweekly check-ins will also be conducted to record your dialysis data and 
any discomfort you may experience. 
4. Compliance Requirements: Please report any changes in your health or 
medication use to the researchers promptly. Do not adjust medication doses 
without medical advice. 
3. Risks 

• 
Routine Medical Risks: Blood tests may cause mild pain or bruising. 
Peritoneal dialysis-related procedures carry a risk of infection (e.g., 
peritonitis), similar to your regular dialysis. 
• 
Solution-Related Reactions: Mild gastrointestinal symptoms (e.g., abdominal 
distension, diarrhea) may occur rarely, which usually improve with dose 
adjustment. 
• 
Metabolic Risks: Transient metabolic acidosis (low blood bicarbonate) may 
occur. Doctors will provide oral sodium bicarbonate to correct it if needed. 
4. Benefits 
• 
You may experience improved nutritional status and stable dialysis adequacy. 
• 
You will receive dedicated follow-up care from Dr. Xue Wen and the study’s 
interdisciplinary treatment team, with free professional consultations. 
• 
More frequent and comprehensive medical monitoring will help detect and 
address dialysis-related issues early. 
Note: Due to individual differences, we cannot guarantee that all participants will 
achieve the expected benefits. 
5. Rights 
• 
Participation is voluntary. You may withdraw from the study at any time 
without affecting your regular medical care or legal rights. 
• 
If you withdraw, you will no longer receive study-specific benefits (e.g., 
dedicated follow-up), but your routine dialysis treatment will continue as 
usual. 
• 
All your personal and medical information will be kept confidential. 
Electronic records will be anonymized with study IDs, and paper records will 
be stored securely. No identifying information will be included in study 
publications. 
6. Contact Information 
For questions about the study, please contact: 
Dr. Xue Wen 
Phone: 19946074784 

Consent Statement 
I voluntarily agree to participate in this study. 
I have been informed of the study’s purpose, procedures, risks, and benefits. I have 
read this consent form (provided in a language I understand), had the opportunity to 
ask questions, and all my questions have been answered to my satisfaction. 
I agree to the collection and use of my health information for research purposes. 
I understand I may withdraw from the study at any time without penalty. 
I acknowledge that signing this form does not waive any of my legal rights. 
I will receive a copy of this signed consent form, and the original will be retained by 
the study center. 
 
Signature 
Date 
Participant’s Signature 
Legal Representative’s Signature (if applicable) 
Witness’s Signature (if participant cannot read) 
Investigator’s Signature