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YSPSL for Prevention of Delayed Graft Function Part B

Primary Purpose

Kidney Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
YSPSL
placebo
YSPSL
Sponsored by
Y's Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Delayed Graft Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dumont-UCLA Transplant Center
  • California Pacific Medical Center Department of Transplantation
  • University of Colorado Health Sciences Center
  • Shands Hospital at University of Florida
  • Lifelink Foundation
  • Rush University Medical Center
  • Tulane University Hospital & Clinic
  • Henry Ford Hospital Transplant Institute
  • Saint Barnabas Medical Center
  • Westchester Medical Center, New York Medical College
  • University of Cincinnati, Department of Internal Medicine
  • Methodist Healthcare University Hospital
  • Baylor University Medical Center Transplantation Services
  • The Methodist Hospital
  • University of Texas, Organ Transplantation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

delayed graft function post transplant

Secondary Outcome Measures

renal function parameters through 6 months post transplant

Full Information

First Posted
February 27, 2006
Last Updated
January 24, 2008
Sponsor
Y's Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00298168
Brief Title
YSPSL for Prevention of Delayed Graft Function Part B
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Y's Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Delayed Graft Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YSPSL
Other Intervention Name(s)
rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
YSPSL
Other Intervention Name(s)
rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig
Intervention Description
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
Primary Outcome Measure Information:
Title
delayed graft function post transplant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
renal function parameters through 6 months post transplant
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Hemmerich, PhD
Organizational Affiliation
Y's Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dumont-UCLA Transplant Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
California Pacific Medical Center Department of Transplantation
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Shands Hospital at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Lifelink Foundation
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Tulane University Hospital & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Henry Ford Hospital Transplant Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Westchester Medical Center, New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
University of Cincinnati, Department of Internal Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Methodist Healthcare University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Baylor University Medical Center Transplantation Services
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas, Organ Transplantation
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21114535
Citation
Cheadle C, Watkins T, Ehrlich E, Barnes K, Gaber AO, Hemmerich S, Rabb H. Effects of anti-adhesive therapy on kidney biomarkers of ischemia reperfusion injury in human deceased donor kidney allografts. Clin Transplant. 2011 Sep-Oct;25(5):766-75. doi: 10.1111/j.1399-0012.2010.01365.x. Epub 2010 Nov 28.
Results Reference
derived
PubMed Identifier
20573162
Citation
Gaber AO, Mulgaonkar S, Kahan BD, Woodle ES, Alloway R, Bajjoka I, Jensik S, Klintmalm GB, Patton PR, Wiseman A, Lipshutz G, Kupiec-Weglinski J, Gaber LW, Katz E, Irish W, Squiers EC, Hemmerich S. YSPSL (rPSGL-Ig) for improvement of early renal allograft function: a double-blind, placebo-controlled, multi-center Phase IIa study. Clin Transplant. 2011 Jul-Aug;25(4):523-33. doi: 10.1111/j.1399-0012.2010.01295.x. Epub 2010 Jun 22.
Results Reference
derived

Learn more about this trial

YSPSL for Prevention of Delayed Graft Function Part B

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