YSPSL for Prevention of Delayed Graft Function Part B

Y's Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Diseases

Treatments: Drug: YSPSL; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298168

YSPSL-0001-PF Part B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: YSPSL

Drug: YSPSL

2

Experimental group

Treatment:

Drug: YSPSL

Drug: YSPSL

3

Placebo Comparator group

Treatment:

Drug: placebo