YSPSL for Prevention of Delayed Graft Function Part B
- Registration Number
- NCT00298168
- Lead Sponsor
- Y's Therapeutics, Inc.
- Brief Summary
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-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 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; 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients undergoing primary cadaver renal transplants
- Patient has a planned transplant of a donor kidney from a non-heart beating donor
- Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant) or from donors < 6 years of age
- Patient has a planned transplant of a kidney from a donor who has received investigational therapies designed to reduce the impact of ischemia/reperfusion (I/R) injury, DGF, or other donor-related immune events
- Patient is planned to receive a living donor kidney; or patient is planned to receive an ABO-incompatible donor kidney
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 placebo - 1 YSPSL - 2 YSPSL -
- Primary Outcome Measures
Name Time Method delayed graft function post transplant 6 months
- Secondary Outcome Measures
Name Time Method renal function parameters through 6 months post transplant 6 months
Trial Locations
- Locations (15)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Baylor University Medical Center Transplantation Services
🇺🇸Dallas, Texas, United States
University of Texas, Organ Transplantation
🇺🇸Houston, Texas, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
California Pacific Medical Center Department of Transplantation
🇺🇸San Francisco, California, United States
Lifelink Foundation
🇺🇸Tampa, Florida, United States
Henry Ford Hospital Transplant Institute
🇺🇸Detroit, Michigan, United States
Methodist Healthcare University Hospital
🇺🇸Memphis, Tennessee, United States
Dumont-UCLA Transplant Center
🇺🇸Los Angeles, California, United States
Westchester Medical Center, New York Medical College
🇺🇸Hawthorne, New York, United States
University of Cincinnati, Department of Internal Medicine
🇺🇸Cincinnati, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Shands Hospital at University of Florida
🇺🇸Gainesville, Florida, United States
Tulane University Hospital & Clinic
🇺🇸New Orleans, Louisiana, United States