Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery

Phase 2 Completed 152 enrolled Renibus Therapeutics, Inc.

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2021-08-04
Primary completion: 2022-11-09
Completion: 2023-02-03

Outcome

Met primary endpoint

paper RBT-1 led to a greater preconditioning response than did placebo at high-dose (geometric least squares mean [GLSM] ratio, 3.58; 95% CI, 2.91-4.41; p <0.0001) PMID 38586479 ↗

release “In a completed Phase 2 study, RBT-1 demonstrated statistically significant positive data in primary and several clinical endpoints” renibus.com ↗

Publications

Results Lamy A, Chertow GM, Jessen M, Collar A, Brown CD, Mack CA, Marzouk M, Scavo V, Washburn TB, Savage D, Smith J, Bennetts J, Assi R, Shults C, Arghami A, Butler J, Devereaux PJ, Zager R, Wang C, Snapinn S, Browne A, Rodriguez J, Ruiz S, Singh B; of START Investigators. Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. EClinicalMedicine. 2024 Jan 8;68:102364. doi: 10.1016/j.eclinm.2023.102364. eCollection 2024 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iron sucrose	Unknown	240 mg	Intravenous
Subject	stannic protoporfin	Small molecule	45 mg	Intravenous
Subject	stannic protoporfin	Small molecule	90 mg	Intravenous