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

February 27, 2006
January 24, 2008
May 2006
September 2007   (final data collection date for primary outcome measure)
delayed graft function post transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
delayed graft function post transplant
Complete list of historical versions of study NCT00298168 on ClinicalTrials.gov Archive Site
renal function parameters through 6 months post transplant [ Time Frame: 6 months ]
renal function parameters through 6 months post transplant
Not Provided
Not Provided
 
YSPSL for Prevention of Delayed Graft Function Part B
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 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Kidney Diseases
  • 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
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: YSPSL
  • Experimental: 2
    Intervention: Drug: YSPSL
  • Placebo Comparator: 3
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298168
YSPSL-0001-PF Part B
Yes
Stefan Hemmerich, PhD, RAC, Y's Therapeutics Inc.
Y's Therapeutics, Inc.
Not Provided
Study Director: Stefan Hemmerich, PhD Y's Therapeutics, Inc.
Y's Therapeutics, Inc.
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP