We will enroll 180 eligible adult recipients of first deceased donor kidney transplants into the study. Consent and enrollment will occur >48 hour prior to transplantation. This is a prospective double-blinded, randomized, placebo-controlled, multiple-center study of adult kidney transplant patients receiving a deceased donor kidney allograft considered high-risk for development of ischemia reperfusion injury. Recipients will be randomized (1:1) to receive donor kidneys treated with a single intrarenal injection of C1INH vs placebo on the back table in the operating room prior to transplantation. As rationalized in our power calculations we require 180 subjects (90 C1INH: 90 placebo) to have adequate power for detecting differences in the 1-year eGFR (primary endpoint) between treatment groups. We will follow subjects for 12 months post-transplant to assess the primary endpoint. We will continue limited follow up for all subjects for 3 years
What is the full name of this clinical trial?
IMPROVING DECEASED-DONOR KIDNEY TRANSPLANT OUTCOMES VIA A SINGLE INTRAGRAFT INJECTION OF C1 ESTERASE INHIBITOR