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NCT04696146 · ClinicalTrials.gov registry record · Phase 1
Berinert (C1INH) vs Placebo for DGF/IRI
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT04696146 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 45 participants.
The verdict
NCT04696146, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Berinert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-03-03 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04696146
The ClinicalTrials.gov registry entry for NCT04696146 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04696146 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04696146 about?
NCT04696146 is a clinical study titled "Berinert (C1INH) vs Placebo for DGF/IRI". 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 consi...
What is the current status of trial NCT04696146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-03-03. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04696146?
The interventions under investigation include: Placebo (DRUG), Berinert (DRUG).
Who is sponsoring clinical trial NCT04696146?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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