YSPSL for Prevention of Delayed Graft Function Part B

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Kidney Diseases

In brief

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.

Key facts

Study ID

NCT00298168

Run by

Y's Therapeutics, Inc.

People needed

60

Starts

2006-05-01

Expected to finish

2007-12-01

Last updated by the study team

2008-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing primary cadaver renal transplants

You may not qualify if…

• 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

Where it is running

• Dumont-UCLA Transplant Center — Los Angeles, California, United States
• California Pacific Medical Center Department of Transplantation — San Francisco, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Shands Hospital at University of Florida — Gainesville, Florida, United States
• Lifelink Foundation — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Tulane University Hospital & Clinic — New Orleans, Louisiana, United States
• Henry Ford Hospital Transplant Institute — Detroit, Michigan, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, 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
• Methodist Healthcare University Hospital — Memphis, Tennessee, United States
• Baylor University Medical Center Transplantation Services — Dallas, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Texas, Organ Transplantation — Houston, Texas, United States

Full record on ClinicalTrials.gov

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