YSPSL for Prevention of Delayed Graft Function Part A

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delayed Graft Function Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dumont-UCLA Transplant Center, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YSPSL

Drug

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

Primary outcomes

delayed graft function post transplant

Time frame: 6 months

Secondary outcomes

renal function parameters through 6 months post transplant

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Y's Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Mar 1, 2006
Registry last updated: Jan 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed