Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298168
Status:
COMPLETED
Last Update Posted:
2008-01-29
First Post:
2006-02-27
Brief Title:
YSPSL for Prevention of Delayed Graft Function Part B
Sponsor:
Ys Therapeutics Inc
Organization:
Ys Therapeutics Inc
Study Overview
Official Title:
Controlled Randomized Prospective Double-Blind Multicenter Phase III Dose-Escalation Study of the Safety PK and Efficacy of YSPSL for Prevention of Delayed Graft Function in Patients Undergoing Cadaveric Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Selectins have been implicated in the pathogenesis of ischemiareperfusion IR-induced kidney injury and resultant delayed graft function DGF PSGL-1 is a ligand for P- E- and L-selectin It has been reported that YSPSL rPSGL-Ig blocks P-selectin and to a lesser degree E- and L-selectin Both sPSGL-1 and YSPSL rPSGL-Ig have been shown in animal models to reduce both cytokines and tissue damage associated with ischemia reperfusion and to improve renal function post-transplant Therefore the current phase III clinical study is designed to assess the safety and efficacy of YSPSL rPSGL-Ig in preventing DGF in patients undergoing cadaveric kidney transplants and to determine a dose for future pivotal studies
Detailed Description:
This will be a multicenter single-dose dose-escalation study The study will be in 2 parts the first Part A will be an open label evaluation of single doses of four dose cohorts the second Part B will be a randomized double-blind placebo-controlled single-dose study of two dose cohorts Patients who are undergoing cadaveric kidney transplantation and are at risk for development of DGF based upon known risk factors will be eligible to participate in the study A maximum of 24 patients will be enrolled in Part A 60 patients will be enrolled in Part B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None