Status:
COMPLETED
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Lead Sponsor:
Guard Therapeutics AB
Conditions:
Acute Kidney Injury (AKI)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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...
Detailed Description
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, follo...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04829916
Start Date
March 16 2021
End Date
July 15 2021
Last Update
April 23 2024
Active Locations (1)
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1
Münster University Hospital
Münster, Germany, DE-481 49