Berinert (C1INH) vs Placebo for DGF/IRI (NCT04696146) | Clinical Trial Compass
CompletedPhase 1/2
Berinert (C1INH) vs Placebo for DGF/IRI
United States45 participantsStarted 2021-03-03
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Adult men or women (18-70 years of age) who are on chronic dialysis therapy and acceptable candidates for receipt of a kidney transplant.
✓. Recipients who are ABO compatible with donor allograft
✓. Understand and sign a written inform consent prior to any study specific procedure
✓. Women of childbearing potential must have a negative pregnancy test prior to randomization, and must be on an acceptable form of birth control.
✓. . AND one of the below criteria:
Exclusion criteria
✕. Patients with a known pro-thrombotic disorder. (eg. Factor V Leiden)
✕. Patients with a history of thrombosis or hypercoagulable state, excluding access clotting.
✕. Patients with a history of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry.
✕. Patients with a known hypersensitivity to treatment with C1INH.
What they're measuring
1
Need for Dialysis in the First 30 Days Post-transplant