Phase 2
N=45
Berinert (C1INH) vs Placebo for DGF/IRI
End Stage Renal Disease · Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04696146 ↗Enrolled (actual)
45
Serious AEs
25.0%
Results posted
Sep 2023
Primary outcome: Primary: Need for Dialysis in the First 30 Days Post-transplant — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Berinert (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Dialysis in the First 30 Days Post-transplant |
10; 10 | — |
| PRIMARY Renal Function 6 Months |
54; 42 | — |
| PRIMARY Graft Survival 6 Months |
20; 20 | — |
| SECONDARY Rejection Episodes at 6 Months |
3; 0 | — |
| SECONDARY Development of Donor Specific Antibodies (DSA) at 6 Months |
1; 1 | — |
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.
Eligibility Criteria
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:
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
- 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.
Data sourced from ClinicalTrials.gov (NCT04696146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.