A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RMC-035 Participants will receive RMC-035 intravenously |
Drug: RMC-035
Multiple dosing during 48 hours following cardiac surgery
Other Names:
|
| Placebo Comparator: Placebo Participants will receive matching placebo solution intravenously |
Drug: Placebo
Multiple dosing during 48 hours following cardiac surgery
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Nature, frequency and severity of AEs [Baseline through day 30]
• To evaluate the safety and tolerability of RMC-035 in subjects undergoing non-emergent, on-pump Coronary Artery Bypass Graft (CABG) and/or valve surgery
Secondary Outcome Measures
- Maximum observed concentration (Cmax) [Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1]
Analysis of RMC-035
- Area under the curve (AUC) [Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1]
Analysis of RMC-035
- Elimination half-life (T1/2) [Blood samples will be taken pre-dose and up to 48 hours after start of Dose 1]
Analysis of RMC-035
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Female and male subjects with an age ≥18 years
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Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
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Subject has at least ONE of the following risk factors for AKI at screening:
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History of LVEF <35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan.
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History of previous open chest cavity cardiac surgery with or without CPB
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Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug
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Age ≥70 years
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Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening
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Documented history of previous AKI before date of screening independent of the etiology of AKI
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Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening
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Documented history of albuminuria, defined as UACR >30 mg/g or > 30 mg/24 hour in a 24-hour urine collection.
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eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Key Exclusion Criteria:
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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
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Subject has surgery scheduled to be performed without CPB ("off-pump")
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Subject has surgery scheduled for aortic dissection
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Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
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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
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Münster University Hospital | Münster | Germany | DE-481 49 |
Sponsors and Collaborators
- Guard Therapeutics AB
Investigators
- Study Director: Tobias Agervald, MD PhD, Guard Therapeutics AB
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-ROS-04