Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Perito
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.
| Condition(s) | End Stage Renal Disease (ESRD) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 peri |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chengdu Qingshan Likang Pharmaceutical Co., Ltd |
| Locations | Hefei, Anhui, China; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Changsha, Hunan, China; Chengdu, Sichuan, China; Chongqing, China (+15 more sites) |
| Start date | 2024-08-09 |
| NCT ID | NCT06597201 |
| Official listing | https://clinicaltrials.gov/study/NCT06597201 |