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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
594
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
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
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