At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 152 enrolled
Drug / intervention
Low Dose RBT-1 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Low Dose RBT-1, High Dose RBT-1, and 1 other intervention for AKI. Completed, enrolled 152 participants across 25 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAKI
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartAug 2021
Primary CompletionNov 2022
Study CompletionFeb 2023
TodayJul 2026
First PostedSep 25, 2020
Enrollment StartAug 4, 2021
Primary CompletionNov 9, 2022
Study CompletionFeb 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.8 years ago
Interventions
Low Dose RBT-1drug
intravenous administration
High Dose RBT-1drug
intravenous administration
Placebodrug
intravenous administration