drugset
drugset / Trial / NCT06021457

Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

NCT06021457 ↗

Phase 3 Completed 454 enrolled Renibus Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2023-10-17
Primary completion
2025-06-17
Completion
2025-06-17

Outcome

Missed primary endpoint

release “While the study did not meet its primary endpoint in the overall population, we observed treatment effect trends in higher-risk patient populations that may inform a more targeted development strategy.” renibus.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject RBT-1 Unknown — Intravenous

Indications

No indication recorded.