Status:
COMPLETED
YSPSL for Prevention of Delayed Graft Function Part A
Lead Sponsor:
Y's Therapeutics, Inc.
Conditions:
Delayed Graft Function
Eligibility:
All Genders
18+ years
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 ...
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, P...
Eligibility Criteria
Inclusion
- primary cadaver renal transplants Other inclusion criteria delineated in protocol
Exclusion
- Full criteria delineated in protocol Patient has a planned transplant of a donor kidney from a non-heartbeating 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00298181
Start Date
October 1 2005
End Date
December 1 2007
Last Update
January 29 2008
Active Locations (10)
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1
Dumont-UCLA Transplant Center
Los Angeles, California, United States, 90095
2
California Pacific Medical Center Department of Transplantation
San Francisco, California, United States, 94115
3
Lifelink Foundation
Tampa, Florida, United States, 33606
4
Rush University Medical Center
Chicago, Illinois, United States, 60612