YSPSL for Prevention of Delayed Graft Function Part A

This study has been completed.

Sponsor:

Information provided by:

Y's Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT00298181

First received: February 27, 2006

Last updated: January 24, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2006

Last Updated Date

January 24, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

delayed graft function post transplant

Change History

Complete list of historical versions of study NCT00298181 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

renal function parameters through 6 months post transplant [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

renal function parameters through 6 months post transplant

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

YSPSL for Prevention of Delayed Graft Function Part A

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Delayed Graft Function

Intervention ^ICMJE

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

Other Names:

rPSGL-Ig
recombinant P-selectin glycoprotein ligand-Ig

Study Group/Cohort (s)

Not Provided

Publications *

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;25(4):523-33. Epub 2010 Jun 22.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00298181

Other Study ID Numbers ^ICMJE

YSPSL-0001-PF Part A

Has Data Monitoring Committee

Yes

Responsible Party

Stefan Hemmerich, PhD, RAC, Y's Therapeutics Inc.

Study Sponsor ^ICMJE

Y's Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Stefan Hemmerich, PhD

Y's Therapeutics, Inc.

Information Provided By

Y's Therapeutics, Inc.

Verification Date

January 2008

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

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