NCT06358820

Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: The People's Hospital of Gaozhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

Interventions

Type	Name	Description
DRUG	Amino acid peritoneal dialysis solution	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

Timeline

• Start date: 2023-12-03
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2024-04-11
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

1 site across 1 country: China