Berinert for Kidney Damage

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

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.

Research Team

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

My blood type matches the donor's for the transplant.

I received a kidney transplant that meets specific high-risk criteria.

I am between 18 and 70 years old, on dialysis, and can receive a kidney transplant.

Exclusion Criteria

I have an active cancer diagnosis.

My kidney match is perfect.

You are allergic to C1INH treatment.

Treatment Details

Interventions

• Berinert (C1 Esterase Inhibitor)
• Placebo (Other)

Trial Overview The trial is testing Berinert (C1INH) against a placebo in preventing delayed graft function after high-risk kidney transplants. It's double-blind and randomized: neither doctors nor patients know who gets real treatment versus placebo. The drug/placebo is given directly into the donated kidney before implantation.

Participant Groups

Group I: Berinert Experimental Treatment 1 Intervention

Berinert 500 units

Group II: Placebo Placebo Group 1 Intervention

Normal Saline in identical volume to Berinert

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

OneLegacy Foundation

Collaborator

Trials

2

Recruited

60+