Status:
COMPLETED
YSPSL for Prevention of Delayed Graft Function Part B
Lead Sponsor:
Y's Therapeutics, Inc.
Conditions:
Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- Patients undergoing primary cadaver renal transplants
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00298168
Start Date
May 1 2006
End Date
December 1 2007
Last Update
January 29 2008
Active Locations (15)
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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
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
4
Shands Hospital at University of Florida
Gainesville, Florida, United States, 32610