At a glance
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A Phase I/II, Double-Blind, Placebo-Controlled Study: Assessing Safety and Efficacy of Preoperative Renal Allograft Infusions of C1 Inhibitor (Berinert®) (Human) (C1INH) vs. Placebo Administration in Recipients of a Renal Allograft From Deceased High Risk Donors and Its Impact on Delayed Graft Function (DGF) and Ischemia/Reperfusion Injury (IRI)
In Brief
A Phase 2 clinical trial evaluating Berinert and Placebo for End Stage Renal Disease and Chronic Kidney Diseases. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intrarenal dose of 500 U of Berinert
Normal Saline placebo