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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborator:
OneLegacy Foundation
Treatments:
Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement C1s