Berinert for Kidney Damage
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Adults aged 18-70 on dialysis and candidates for high-risk kidney transplants from deceased donors can join. They must understand the study, use birth control if applicable, and match the donor's blood type. Excluded are those with clotting disorders, recent C1INH treatments, certain infections (Hep B/C, HIV), pregnancy or breastfeeding women, preemptive transplant recipients, zero mismatch kidneys recipients.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Berinert (C1 Esterase Inhibitor)
- Placebo (Other)