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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00298181
Other study ID # YSPSL-0001-PF Part A
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 27, 2006
Last updated January 24, 2008
Start date October 2005
Est. completion date December 2007

Study information

Verified date January 2008
Source Y's Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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 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.


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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2007
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- primary cadaver renal transplants Other inclusion criteria delineated in protocol

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Drug:
YSPSL
YSPSL administered intravenously (IV) as a single bolus infusion open-label at 0.07, 0.22, 0.7 or 2.2 mg/kg

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois
United States University of Cincinnati, Department of Internal Medicine Cincinnati Ohio
United States Baylor University Medical Center Transplantation Services Dallas Texas
United States Westchester Medical Center, New York Medical College Hawthorne New York
United States University of Texas, Organ Transplantation Houston Texas
United States Saint Barnabas Medical Center Livingston New Jersey
United States Dumont-UCLA Transplant Center Los Angeles California
United States Methodist Healthcare University Hospital Memphis Tennessee
United States California Pacific Medical Center Department of Transplantation San Francisco California
United States Lifelink Foundation Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Y's Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary delayed graft function post transplant 6 months Yes
Secondary renal function parameters through 6 months post transplant 6 months
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