A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Condition: Acute Kidney Injury (AKI)
MeSH terms: Acute Kidney Injury
Intervention: RMC-035; Placebo
Intervention description: Multiple dosing during 48 hours following cardiac surgery; Multiple dosing during 48 hours following cardiac surgery
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: AKI

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 <35% for at least 3 months prior to screening assessed by either
                  echocardiography, cardiac MRI or nuclear scan.

               -  History of previous open chest cavity cardiac surgery with or without CPB

               -  Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to
                  screening AND ongoing treatment with an approved anti-diabetic drug

               -  Age ≥70 years

               -  Documented history of heart failure NYHA class II or higher for at least 3 months
                  or longer at screening

               -  Documented history of previous AKI before date of screening independent of the
                  etiology of AKI

               -  Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least
                  3 months prior to screening

               -  Documented history of albuminuria, defined as UACR >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)