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NCT06021457 · ClinicalTrials.gov registry record · Phase 3
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
A Phase 3 study, sponsored by Renibus Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
NCT06021457: Completed Phase 3 study, sponsored by Renibus Therapeutics.
NCT06021457 is a Phase 3 study that has completed, run by Renibus Therapeutics. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06021457, a Phase 3 study, has completed, sponsored by Renibus Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.
Primary Outcome
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
Interventions
- DRUG Placebo
- DRUG RBT-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2025-06-17 |
| Phase | Phase 3 |
What the finished NCT06021457 record still lists
NCT06021457 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06021457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06021457 about?
NCT06021457 is a clinical study titled "Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery". The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-...
What is the current status of trial NCT06021457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2023-10-17. Estimated completion is 2025-06-17.
What interventions are being tested in trial NCT06021457?
The interventions under investigation include: Placebo (DRUG), RBT-1 (DRUG).
Who is sponsoring clinical trial NCT06021457?
This trial is sponsored by Renibus Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06021457's enrollment target sits among peer trials
454 831st of 2000 higher than 1,167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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