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.
This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
13
Münster University Hospital
Münster, Germany
Frequency of Adverse Events (AEs)
* number (%) of subjects with at least one AE * number (%) of subjects with at least one SAE * number (%) of subjects with at least one Treatment-Emergent AE (TEAE) * number (%) of subjects with at least one serious TEAE * number (%) of subjects with at least one non-serious TEAE * number (%) of subjects with at least one TEAE of special interest * number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP * number (%) of subjects with at least one TEAEs leading to withdrawal of IMP
Time frame: Baseline through day 30
Severity of AEs
\- Number of TEAEs per category (mild, moderate, severe life-threatening, death)
Time frame: Within 4 days from first dose of IMP
Maximum Observed Concentration (Cmax)
Analysis of RMC-035 concentration in plasma (AUC + t1/2) after fourth infusion.
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Area Under the Curve (AUC) 0-24h
Analysis of RMC-035 concentrations in plasma following the fourth infusion.
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Elimination Half-life (T1/2)
Analysis of RMC-035 concentration in plasma following the fourth infusion
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
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