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

NCT06597201 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-12-30

No results posted yet for this study

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.

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

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.

Sponsors & Collaborators

  • Chengdu Qingshan Likang Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2025-06-29
Completion
2025-06-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597201 on ClinicalTrials.gov