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NCT04564833 · ClinicalTrials.gov registry record · Phase 2
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
A Phase 2 study of AKI, sponsored by Renibus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 20
- Study locations
NCT04564833: Completed Phase 2 study of AKI, sponsored by Renibus Therapeutics.
NCT04564833 is a Phase 2 study of AKI that has completed, run by Renibus Therapeutics. The registered enrollment target is 152 participants, above the 54-participant average among 4 other AKI trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04564833, a Phase 2 study of AKI, has completed, sponsored by Renibus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
Primary Outcome
Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low Dose RBT-1
- DRUG High Dose RBT-1
Study Locations (20)
California
- Keck Hospital of USC - Los Angeles
- Santa Barbara Cottage Hospital - Santa Barbara
- Stanford University Medical Center - Stanford
New York
- New York Presbyterian-Queens - Flushing
- Columbia University Irving Medical Center - New York
- Rochester General Hospital Center for Clinical Research - Rochester
Indiana
- Indiana University Health Southern Indiana - Bloomington
- Lutheran Medical Group - Fort Wayne
Michigan
- McLaren Greater Lansing - Lansing
- MyMichigan Medical Center - Midland
Alabama
- Heart Center Research, LLC - Huntsville
Connecticut
- Yale University School of Medicine - New Haven
District of Columbia
- MedStar Health Research Institute, Inc. - Washington D.C.
Illinois
- University of Chicago Hospital Anesthesia and Critical Care - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2021-08-04 |
| Est. Completion | 2023-02-03 |
| Phase | Phase 2 |
What the finished NCT04564833 record still lists
NCT04564833 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 54-participant average among 4 other AKI trials with a reported enrollment target (181% higher).
The record links to 1 condition, with AKI appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04564833 names 20 study sites across 14 states, led by California, New York, Indiana.
Frequently Asked Questions
What is clinical trial NCT04564833 about?
NCT04564833 is a clinical study titled "Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery". The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
What is the current status of trial NCT04564833?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2021-08-04. Estimated completion is 2023-02-03.
What conditions does trial NCT04564833 study?
This clinical trial studies the following conditions: AKI.
What interventions are being tested in trial NCT04564833?
The interventions under investigation include: Placebo (DRUG), Low Dose RBT-1 (DRUG), High Dose RBT-1 (DRUG).
Who is sponsoring clinical trial NCT04564833?
This trial is sponsored by Renibus Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04564833 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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