NCT06021457

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Renibus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Operative Complications in Cardiac Surgery

Interventions

Type	Name	Description
DRUG	RBT-1	Intravenous administration
DRUG	Placebo	Intravenous administration

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2023-09-01
• Last updated: 2025-08-01

Locations

41 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study