NCT04086212

Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine

Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Iperboreal Pharma Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD solution for long dwell exchange.

Detailed description

The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. The other major advantage of IXC is the reduced exposure and absorption of glucose as the main osmotic agent in PD therapy. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal IXC-based PD solution. Compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. As a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. Moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	Icodextrin, xylitol and carnitine solution for peritoneal dialysis	Patients will receive a long dwell exchange for three days.
DRUG	EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution	Patients will receive a long dwell exchange for three days.

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2019-09-11
• Last updated: 2024-10-01