drugset / Trial / NCT04001036

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

NCT04001036

Phase 2 Terminated 11 enrolled Iperboreal Pharma Srl
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

EvaluationDrugModalityDoseRoute
Subject Glucose Unknown 0.5 %
Subject L-carnitine Other / unclassified 0.02 %
Subject Xylitol Small molecule 0.7 %
Subject Xylitol Small molecule 1.5 %