Clinical trial NCT06358820: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution
Official title: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status of Maintenance Peritoneal Dialysis Patients
Keywords: amino acid peritoneal dialysis solution；peritoneal dialysis
Lead sponsor: The People's Hospital of Gaozhou
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level\<3.5g/dL (35g/L), (2) prealbumin\<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of\>7;
2. Blood urea nitrogen ≤ 38mmol/L;
3. The patient's age is between 18 and 75 years old;
4. The patient signs an informed consent form.

Exclusion Criteria:

1. Individuals who are allergic to any amino acids or excipients in this product
2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
3. Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
4. Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;

6. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.

Primary outcomes:
measure: blood albumin
timeFrame: Baseline, 3 months, 6 months
measure: prealbumin
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaozhou
country: China
facility: Gaozhou People's Hospital
state: Guangdong
Study officials:
References: