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YSPSL for Prevention of Delayed Graft Function Part A

NCT00298181 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2008-01-29

No results posted yet for this study

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.

Conditions

  • Delayed Graft Function

Interventions

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

Sponsors & Collaborators

  • Y's Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Hemmerich, PhD · Y's Therapeutics, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-11-30
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298181 on ClinicalTrials.gov