Phase 1
N=12
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Acute Kidney Injury (AKI)
Bottom Line
View on ClinicalTrials.gov: NCT04829916 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Dec 2023
Primary outcome: Primary: Frequency of Adverse Events (AEs) — 6; 1; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RMC-035 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guard Therapeutics AB
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events (AEs) |
6; 1; 3; 1; 5; 1 | — |
| PRIMARY Severity of AEs |
3; 1; 5; 2; 3; 2 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
12.3 | — |
| SECONDARY Area Under the Curve (AUC) 0-24h |
38.3 | — |
| SECONDARY Elimination Half-life (T1/2) |
4.5 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
- Female and male subjects with an age ≥18 years
- Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
- Subject has at least ONE of the following risk factors for AKI at screening:
- History of LVEF 30 mg/g or > 30 mg/24 hour in a 24-hour urine collection.
- eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Key Exclusion Criteria
- Estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline
- Subject has surgery scheduled to be performed without CPB ("off-pump")
- Subject has surgery scheduled for aortic dissection
- Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
- Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation
- Subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary)
Data sourced from ClinicalTrials.gov (NCT04829916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.