Clinical Trial: QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 D
Brief 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 Summary: 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.
Sponsor: Quark Pharmaceuticals
Current Primary Outcome: The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant. [ Time Frame: Day 0 to Day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant. [ Time Frame: Day 0 to Day 7 ]
- The proportion of subjects with a decrease in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant. [ Time Frame: Day 0 to Day 7 ]
Original Secondary Outcome: Same as current
Information By: Quark Pharmaceuticals
Dates:
Date Received: November 18, 2015
Date Started: December 2015
Date Completion: December 2019
Last Updated: November 9, 2016
Last Verified: November 2016
