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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: Completed Phase 1 study, sponsored by Cedars-Sinai Medical Center.
NCT04696146 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of patients enrolled who require at least one session of dialysis in the first 30 days post transplant.
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 |
What the finished NCT04696146 record still lists
NCT04696146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04696146 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04696146's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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