NCT06597201 Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
| NCT ID | NCT06597201 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chengdu Qingshan Likang Pharmaceutical Co., Ltd |
| Condition | End Stage Renal Disease (ESRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-08-09 |
| Primary Completion | 2025-06-29 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 18 to 75 years of age (including 18 and 75 years of age), regardless of sex; 2. Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months; 3. 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart); 4. Blood potassium ≥ 3.5 mmol/L 5. C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN); 6. Carbon dioxide binding capacity \>18 mmol/L; 7. Subjects voluntarily sign an informed consent form in writing prior to the commencement of any procedures related to the study, fully understand the purpose and significance of the trial, and are willing to comply with the trial protocol. Exclusion Criteria: 1. Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records; 2. The possibility of receiving a kidney transplant during the study period; 3. Patients with inadequate dialysis and