NCT00298181

YSPSL for Prevention of Delayed Graft Function Part A

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 Function in Patients Undergoing Cadaveric Kidney Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Y's Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 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.

Conditions

• Delayed Graft Function

Interventions

Type	Name	Description
DRUG	YSPSL	YSPSL administered intravenously (IV) as a single bolus infusion open-label at 0.07, 0.22, 0.7 or 2.2 mg/kg

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-11-01
• Completion: 2007-12-01
• First posted: 2006-03-01
• Last updated: 2008-01-29

Locations

10 sites across 1 country: United States