NCT04696146CompletedPhase 1/2
Berinert (C1INH) vs Placebo for DGF/IRI
A Phase I/II, Double-Blind, Placebo-Controlled Study: Assessing Safety and Efficacy of Preoperative Renal Allograft Infusions of C1 Inhibitor (Berinert®) (Human) (C1INH) vs. Placebo Administration in Recipients of a Renal Allograft From Deceased High Risk Donors and Its Impact on Delayed Graft Function (DGF) and Ischemia/Reperfusion Injury (IRI)
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 22 Dec 2020
- Start date
- 3 Mar 2021
- Primary completion date
- 31 Jul 2022
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT04696146
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 45
- From 3 Mar 2021 to the primary completion date, 31 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Recipients of pre-emptive kidney transplantation.
- Recipients of kidney allograft that was on pump preservation for any period prior to transplantation.
Other illness
- 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 known active presence of malignancies.
- Patients who arePCR positive for Hep B, Hep C, or HIV.
Lab values
- Patients with an abnormal coagulation function. (INR\>2, PTT\> 50, PLT\<60,000)who are not on anti-coagulation.
Other
- All zero mismatch kidneys.
- Recipients of multi-organ transplants. (kidney and any other organ)
- Recipients of kidney allograft from a living donor.13)Female subjects who are pregnant or lactating.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.