Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04001036
Status:
TERMINATED
Last Update Posted:
2023-03-03
First Post:
2019-06-26
Brief Title:
Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose Xylitol and L-Carnitine in CAPD
Sponsor:
Iperboreal Pharma Srl
Organization:
Iperboreal Pharma Srl
Study Overview
Official Title:
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
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prematurely interrupted due to significant difficulties in the completion of the sample size defined by the study protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective randomized controlled clinical trial The aim is to compare the effects of the peritoneal dialysis solution IPX15 containing glucose 05 xylitol 15 and L-carnitine 002 as osmotic agents comparable to the standard 25 glucose PD solution for the nocturnal exchange with the PD solution IPX07 containing glucose 05 xylitol 07 and L-carnitine 002 as osmotic agents comparable to the standard 15 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
Detailed Description:
None
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