YSPSL for Prevention of Delayed Graft Function Part A

January 24, 2008 updated by: Y's Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Dumont-UCLA Transplant Center
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Department of Transplantation
    • Florida
      • Tampa, Florida, United States, 33606
        • Lifelink Foundation
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
    • New York
      • Hawthorne, New York, United States, 10532
        • Westchester Medical Center, New York Medical College
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati, Department of Internal Medicine
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare University Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center Transplantation Services
      • Houston, Texas, United States, 77030
        • University of Texas, Organ Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
delayed graft function post transplant
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
renal function parameters through 6 months post transplant
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Y's Therapeutics, Inc.

Investigators

  • Study Director: Stefan Hemmerich, PhD, Y's Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YSPSL-0001-PF Part A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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