Trials / Completed
CompletedNCT04564833
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 152 (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 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low Dose RBT-1 | intravenous administration |
| DRUG | High Dose RBT-1 | intravenous administration |
| DRUG | Placebo | intravenous administration |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2022-11-09
- Completion
- 2023-02-03
- First posted
- 2020-09-25
- Last updated
- 2024-04-15
- Results posted
- 2024-01-16
Locations
25 sites across 3 countries: United States, Australia, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04564833. Inclusion in this directory is not an endorsement.