Status:
COMPLETED
Berinert (C1INH) vs Placebo for DGF/IRI
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
OneLegacy Foundation
Conditions:
End Stage Renal Disease
Chronic Kidney Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Pre-operative, infusion of C1INH into the renal allograft artery 1-2 hours prior to implantation will improve early graft function and reduce the rate of DGF, requirements for dialysis, graft survival...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
- Patients with an abnormal coagulation function. (INR\>2, PTT\> 50, PLT\<60,000)who are not on anti-coagulation.
- Patients with known active presence of malignancies.
- Patients who arePCR positive for Hep B, Hep C, or HIV.
- Recipients of pre-emptive kidney transplantation.
- All zero mismatch kidneys.
- Recipients of multi-organ transplants. (kidney and any other organ)
- Recipients of kidney allograft that was on pump preservation for any period prior to transplantation.
- Recipients of kidney allograft from a living donor.13)Female subjects who are pregnant or lactating.
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04696146
Start Date
March 3 2021
End Date
October 31 2024
Last Update
December 4 2024
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048