Berinert (C1INH) vs Placebo for DGF/IRI

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: OneLegacy Foundation
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Inclusion Criteria:

1. Adult men or women (18-70 years of age) who are on chronic dialysis therapy and acceptable candidates for receipt of a kidney transplant.

2. Recipients who are ABO compatible with donor allograft

3. Understand and sign a written inform consent prior to any study specific procedure

4. Women of childbearing potential must have a negative pregnancy test prior to randomization, and must be on an acceptable form of birth control.

5. . AND one of the below criteria:

a)Recipients of kidney allograft from KDPI >80 donors b)Recipients of kidney allograft from DCD donors c)Recipients of kidney allograft with CIT > 24 hours d)Recipients of kidney allograft from donor on HD/CRRT prior to death/procurement e)Recipients of kidney allograft with donor terminal creatinine SCr ≥3.0 mg/dL f)Patient risk a total risk index score of >/=3

Exclusion Criteria:

1. Patients with a known pro-thrombotic disorder. (eg. Factor V Leiden)

2. Patients with a history of thrombosis or hypercoagulable state, excluding access clotting.

3. Patients with a history of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry.

4. Patients with a known hypersensitivity to treatment with C1INH.

5. Patients with an abnormal coagulation function. (INR>2, PTT> 50, PLT<60,000)who are not on anti-coagulation.

6. Patients with known active presence of malignancies.

7. Patients who arePCR positive for Hep B, Hep C, or HIV.

8. Recipients of pre-emptive kidney transplantation.

9. All zero mismatch kidneys.

10. Recipients of multi-organ transplants. (kidney and any other organ)

11. Recipients of kidney allograft that was on pump preservation for any period prior to transplantation.

12. Recipients of kidney allograft from a living donor.13)Female subjects who are pregnant or lactating.