drugset / Trial / NCT06597201
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-08-09
- Primary completion
- 2025-06-29
- Completion
- 2025-06-29
Publications
- Background My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470.
- Background Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164.
- Background Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | amino acid (15) peritoneal dialysis solution | Unknown | 2000 ml | Other |
| Comparator | glucose peritoneal dialysis solution | Unknown | 2000 ml | Other |