At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
RMC-035 +1 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 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery
In Brief
A Phase 1 clinical trial evaluating RMC-035 and Placebo for Acute Kidney Injury (AKI). Completed, enrolled 13 participants across 1 site.
Detailed Summary
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury (AKI)
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedApr 2021
Primary CompletionJul 2021
TodayJul 2026
First PostedApr 2, 2021
Enrollment StartMar 16, 2021
Primary CompletionJul 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.3 years ago
Interventions
RMC-035drug
Multiple dosing during 48 hours following cardiac surgery
Placebodrug
Multiple dosing during 48 hours following cardiac surgery