NCT02610296

QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: Quark Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors \>45 years after brain death (DBD).

Detailed description

This is a Phase 3 randomized, placebo-controlled, double-blind, multi-center trial stratified by donor age and by region to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from DBD donors who were at least 45 years of age.

Conditions

• Delayed Graft Function

Interventions

Type	Name	Description
DRUG	QPI-1002	IV injection
OTHER	Placebo	isotonic saline

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-06-28
• Completion: 2019-01-08
• First posted: 2015-11-20
• Last updated: 2020-05-13

Locations

84 sites across 11 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Netherlands, Spain