YSPSL for Prevention of Delayed Graft Function Part B
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
1 other identifier
interventional
60
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2006
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 29, 2008
January 1, 2008
1.3 years
February 27, 2006
January 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
delayed graft function post transplant
6 months
Secondary Outcomes (1)
renal function parameters through 6 months post transplant
6 months
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
0.9% normal saline administered IV as a single bolus infusion with 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Dumont-UCLA Transplant Center
Los Angeles, California, 90095, United States
California Pacific Medical Center Department of Transplantation
San Francisco, California, 94115, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Shands Hospital at University of Florida
Gainesville, Florida, 32610, United States
Lifelink Foundation
Tampa, Florida, 33606, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112, United States
Henry Ford Hospital Transplant Institute
Detroit, Michigan, 48202, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Westchester Medical Center, New York Medical College
Hawthorne, New York, 10532, United States
University of Cincinnati, Department of Internal Medicine
Cincinnati, Ohio, 45267, United States
Methodist Healthcare University Hospital
Memphis, Tennessee, 38104, United States
Baylor University Medical Center Transplantation Services
Dallas, Texas, 75246, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Texas, Organ Transplantation
Houston, Texas, 77030, United States
Related Publications (2)
Cheadle C, Watkins T, Ehrlich E, Barnes K, Gaber AO, Hemmerich S, Rabb H. Effects of anti-adhesive therapy on kidney biomarkers of ischemia reperfusion injury in human deceased donor kidney allografts. Clin Transplant. 2011 Sep-Oct;25(5):766-75. doi: 10.1111/j.1399-0012.2010.01365.x. Epub 2010 Nov 28.
PMID: 21114535DERIVEDGaber AO, Mulgaonkar S, Kahan BD, Woodle ES, Alloway R, Bajjoka I, Jensik S, Klintmalm GB, Patton PR, Wiseman A, Lipshutz G, Kupiec-Weglinski J, Gaber LW, Katz E, Irish W, Squiers EC, Hemmerich S. YSPSL (rPSGL-Ig) for improvement of early renal allograft function: a double-blind, placebo-controlled, multi-center Phase IIa study. Clin Transplant. 2011 Jul-Aug;25(4):523-33. doi: 10.1111/j.1399-0012.2010.01295.x. Epub 2010 Jun 22.
PMID: 20573162DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stefan Hemmerich, PhD
Y's Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 27, 2006
First Posted
March 1, 2006
Study Start
May 1, 2006
Primary Completion
September 1, 2007
Study Completion
December 1, 2007
Last Updated
January 29, 2008
Record last verified: 2008-01