NCT06597201

Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

Multicenter, Prospective, Open-label, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.

Detailed description

After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	amino acid (15) peritoneal dialysis solution	Subjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
DRUG	glucose peritoneal dialysis solution	Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-06-29
• Completion: 2025-06-29
• First posted: 2024-09-19
• Last updated: 2024-12-30

Locations

21 sites across 1 country: China