Clinical Trial: YSPSL for Prevention of Delayed Graft Function Part A

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Efficacy of YSPSL for Prevention of Delayed Graft Functio

Brief Summary: Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant DGF. PSGL-1 is a ligand for P-, E-, and L-selectin. It has been reported that 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 I/II 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 Summary: 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 and the second, Part B will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation 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 of the study. 60 patients will be enrolled in Part B.
Sponsor: Y's Therapeutics, Inc.

Current Primary Outcome: delayed graft function post transplant [ Time Frame: 6 months ]

Original Primary Outcome: delayed graft function post transplant

Current Secondary Outcome: renal function parameters through 6 months post transplant [ Time Frame: 6 months ]

Original Secondary Outcome: renal function parameters through 6 months post transplant

Information By: Y's Therapeutics, Inc.

Dates:
Date Received: February 27, 2006
Date Started: October 2005
Date Completion:
Last Updated: January 24, 2008
Last Verified: January 2008