NCT04001036

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

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Iperboreal Pharma Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine	One bag for nocturnal (long-dwell) exchange.
DRUG	0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine	One to three, daily (short-dwell) exchanges

Timeline

• Start date: 2019-09-01
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2019-06-27
• Last updated: 2023-03-03

Locations

1 site across 1 country: Italy