Berinert (C1INH) vs Placebo for DGF/IRI

Summary

This is a Phase I/II double-blind, randomized, placebo-controlled study assessing safety and limited efficacy of intraoperative C1INH (500U/kidney) vs. Placebo administered into the graft renal artery 1-2 hours prior to implantation in adult subjects receiving a deceased donor kidney allograft considered high-risk for development of DGF (KDPI\>80). Once eligible patients are identified, consented, and have an acceptable kidney transplant offer, they will be randomized by the Cedars-Sinai Research Pharmacy to receive study drug vs. placebo. Drug and placebo will be prepared by the Cedars-Sinai Research Pharmacy and conveyed to the operating room in a blinded manner. The drug will be administered by the transplant surgeon in the OR in a blinded manner.

Timeline

Start

2021-03-03

Primary completion

2022-07-31

Completion

2024-10-31

Publications

• Huang E, Ammerman N, Vo A, Hou J, Kumar S, Badash N, Falk B, Hernando K, Gillespie M, Kim IK, Lim K, Najjar R, Peng A, Shin B, Steggerda JA, Todo T, Brennan TV, Voidonikolas G, Wisel SA, Heeger PS, Jordan SC. Back-table intra-arterial administration of C1 esterase inhibitor to deceased donor kidney allografts improves posttransplant allograft function: Results of a randomized double-blind placebo-controlled clinical trial. Am J Transplant. 2025 Sep;25(9):1926-1939. doi: 10.1016/j.ajt.2025.05.003. Epub 2025 May 9.

Drugs

Indications