drugset / Trial / NCT04001036
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD
RandomizedParallel-groupOpen-labelTreatment
Summary
Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2022-08-30
- Completion
- 2022-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glucose | Unknown | 0.5 % | — |
| Subject | L-carnitine | Other / unclassified | 0.02 % | — |
| Subject | Xylitol | Small molecule | 0.7 % | — |
| Subject | Xylitol | Small molecule | 1.5 % | — |