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Sponsored by: |
Y's Therapeutics, Inc. |
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Information provided by: | Y's Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00298181 |
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 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.
Condition | Intervention | Phase |
---|---|---|
Delayed Graft Function |
Drug: YSPSL |
Phase I Phase II |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | 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 |
Enrollment: | 15 |
Study Start Date: | October 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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, Part B will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation 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 of the study. 60 patients will be enrolled in Part B.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
California Pacific Medical Center Department of Transplantation | |
San Francisco, California, United States, 94115 | |
Dumont-UCLA Transplant Center | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
Lifelink Foundation | |
Tampa, Florida, United States, 33606 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, New Jersey | |
Saint Barnabas Medical Center | |
Livingston, New Jersey, United States, 07039 | |
United States, New York | |
Westchester Medical Center, New York Medical College | |
Hawthorne, New York, United States, 10532 | |
United States, Ohio | |
University of Cincinnati, Department of Internal Medicine | |
Cincinnati, Ohio, United States, 45267 | |
United States, Tennessee | |
Methodist Healthcare University Hospital | |
Memphis, Tennessee, United States, 38104 | |
United States, Texas | |
Baylor University Medical Center Transplantation Services | |
Dallas, Texas, United States, 75246 | |
University of Texas, Organ Transplantation | |
Houston, Texas, United States, 77030 |
Study Director: | Stefan Hemmerich, PhD | Y's Therapeutics, Inc. |
Responsible Party: | Y's Therapeutics Inc. ( Stefan Hemmerich, PhD, RAC ) |
Study ID Numbers: | YSPSL-0001-PF Part A |
Study First Received: | February 27, 2006 |
Last Updated: | January 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00298181 |
Health Authority: | United States: Food and Drug Administration |
Delayed Graft Function PS-K |
Pathologic Processes |