YSPSL for Prevention of Delayed Graft Function Part B

This study has been completed.
Sponsor:
Information provided by:
Y's Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00298168
First received: February 27, 2006
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Kidney Diseases
Drug: YSPSL
Drug: placebo
Phase 1
Phase 2

Y's Therapeutics, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Y's Therapeutics, Inc.:

Primary Outcome Measures:
  • delayed graft function post transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • renal function parameters through 6 months post transplant [ Time Frame: 6 months ]

Enrollment: 60
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: YSPSL
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
Other Names:
  • rPSGL-Ig
  • recombinant P-selectin glycoprotein ligand-Ig
Experimental: 2 Drug: YSPSL
YSPSL administered intravenously (IV) as a single bolus infusion of 1 mg/kg with 10 mg YSPSL in 200 mL Lactated Ringer's for Injection USP total volume administered as an ex vivo flush intra-arterially to donor organ prior to implantation
Other Names:
  • rPSGL-Ig
  • recombinant P-selectin glycoprotein ligand-Ig
Placebo Comparator: 3 Drug: placebo
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

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; the second, Part B will be a randomized, double-blind, placebo-controlled, single-dose 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. 60 patients will be enrolled in Part B.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing primary cadaver renal transplants

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298168

Locations
United States, California
Dumont-UCLA Transplant Center
Los Angeles, California, United States, 90095
California Pacific Medical Center Department of Transplantation
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
Shands Hospital at University of Florida
Gainesville, Florida, United States, 32610
Lifelink Foundation
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University Hospital & Clinic
New Orleans, Louisiana, United States, 70112
United States, Michigan
Henry Ford Hospital Transplant Institute
Detroit, Michigan, United States, 48202
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
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Y's Therapeutics, Inc.
Investigators
Study Director: Stefan Hemmerich, PhD Y's Therapeutics, Inc.
  More Information

No publications provided by Y's Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Hemmerich, PhD, RAC, Y's Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00298168     History of Changes
Other Study ID Numbers: YSPSL-0001-PF Part B
Study First Received: February 27, 2006
Last Updated: January 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Y's Therapeutics, Inc.:
Delayed Graft Function

Additional relevant MeSH terms:
Kidney Diseases
Delayed Graft Function
Urologic Diseases
Pathologic Processes
Krestin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014