Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04086212
Status:
WITHDRAWN
Last Update Posted:
2022-03-29
First Post:
2019-09-02
Brief Title:
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Sponsor:
Iperboreal Pharma Srl
Organization:
Iperboreal Pharma Srl
Study Overview
Official Title:
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone an Exploratory Study
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
The study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None