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

End Stage Renal Disease (ESRD) Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04086212
Study type Interventional
Source Iperboreal Pharma Srl
Contact Arduino Arduini, MD
Phone +39.333.6409595
Email a.arduini@iperboreal.com
Status Not yet recruiting
Phase Phase 2
Start date September 2022
Completion date April 2023
View Details
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