Phase IV Study of Amino Acid 15 Peritoneal Dialysis Solution for Patients on Peritoneal Dialysis with Malnutrition Evaluating Safety and Effectiveness Compared to Glucose Dialysis Solution

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an amino acid 15 peritoneal dialysis solution in patients undergoing peritoneal dialysis who have malnutrition. This Phase IV, multicenter, randomized, parallel controlled study focuses on patients receiving continuous ambulatory peritoneal dialysis CAPD maintenance treatment. The goal is to compare the amino acid solution with conventional glucose peritoneal dialysis solution in this population with End Stage Renal Disease ESRD. Participants are randomly assigned to one of two groups an experimental group receiving one bag of amino acid 15 peritoneal dialysate 2 liters each morning followed by conventional glucose dialysate, and a control group receiving conventional glucose peritoneal dialysis solution including 1.5% glucose dialysate 2 liters once daily. The number of dialysate exchanges, fluid volume, and dwell times are adjusted based on individual patient needs. The treatment period lasts 90 days, during which safety and effectiveness are monitored. Participants undergo screening, baseline assessments, and regular monitoring throughout the study. Blood tests and biochemical markers are checked at 30, 60, and 90 days, including serum albumin, transferrin, and prealbumin levels. Nutritional and physical assessments such as subjective global assessment SGA, arm muscle circumference AMC, mid-arm muscle circumference MAMC, body mass index BMI, and protein nitrogen appearance nPNA are evaluated at 90 days. The study also tracks total daily ultrafiltration volume and records all adverse events. The entire participation timeline includes a screening period before treatment and close observation during the 90-day treatment phase.

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