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A Phase 2, Multi-center, Randomized, Dose-Ranging, Placebo-Controlled, Double-blind Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated - Acute Kidney Injury.
EU CTIS ID: 2025-523037-25-00
What this study is testing
To evaluate the safety and efficacy of R2R01 for prevention of AKI (KDIGO definition) after cardiac surgery (CABG, valve surgery, aortic surgery, or a combination of the above) involving CPB, in subjects with additional risk factors for developing CSA-AKI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF)
- At least 18 years of age
- Subject is scheduled for non-emergent CABG (single or multiple vessels), valve surgery (single or multiple valves), surgery of the ascending part of the aorta, or a combination of the above, involving cardiopulmonary bypass (CPB), AND risk factors for acute kidney injury (AKI) are present (at screening) as specified below: a. If only one type of surgery is scheduled, at least two AKI risk factors should be present b. If any combined surgery is scheduled, at least one AKI risk factor should be present. Risk factors for AKI: • Diabetes mellitus on pharmacological treatment • Confirmed diagnosis of hypertension • Documented history of Chronic Heart Failure with New York Heart Association (NYHA) class III or higher (see section 11.5 in Appendix) • Left ventricular ejection fraction (LVEF) ≤40% • Peripheral vascular disease defined as one or more of the following: claudication, carotid occlusion or >50% stenosis, amputation for arterial disease, previous or planned intervention on the abdominal aorta, limb arteries or carotids • Stroke/transient ischemic attack (TIA) defined as sudden onset of focal or global brain, spinal cord, or retinal vascular damage, resulting in symptoms and signs of acute nervous system defects, associated with cerebral circulation disorders • Documented atrial fibrillation (AF) on the ECG performed at the screening visit • Anemia with hemoglobin ≤11 g/dL at any time during the 3-month period before or at the time of screening • Body Mass Index (BMI) ≥ 30 kg/m2 • Age ≥70 years at the time of screening
- Have stable renal function per Investigator assessment
- Subject agrees not to participate in another interventional study after signing the ICF and until the end of study (EoS) visit has been completed
You likely can't join if
- Patient currently enrolled into another interventional clinical trial
- Patient with a kidney transplant
- Subject has a known or suspected glomerulonephritis at the time of randomization
- Cardiogenic shock, hemodynamic instability, mechanical ventilation, intra-aortic balloon pump (IABP), left ventricular assist device (LVAD) or other forms of mechanical circulatory support (MCS), within 7 days prior to surgery
- Patient received inotropes or vasopressors within 48 hours prior to the day of surgery
- Known or suspected sepsis
See the full eligibility criteria
Who can join
- Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF)
- At least 18 years of age
- Subject is scheduled for non-emergent CABG (single or multiple vessels), valve surgery (single or multiple valves), surgery of the ascending part of the aorta, or a combination of the above, involving cardiopulmonary bypass (CPB), AND risk factors for acute kidney injury (AKI) are present (at screening) as specified below: a. If only one type of surgery is scheduled, at least two AKI risk factors should be present b. If any combined surgery is scheduled, at least one AKI risk factor should be present. Risk factors for AKI: • Diabetes mellitus on pharmacological treatment • Confirmed diagnosis of hypertension • Documented history of Chronic Heart Failure with New York Heart Association (NYHA) class III or higher (see section 11.5 in Appendix) • Left ventricular ejection fraction (LVEF) ≤40% • Peripheral vascular disease defined as one or more of the following: claudication, carotid occlusion or >50% stenosis, amputation for arterial disease, previous or planned intervention on the abdominal aorta, limb arteries or carotids • Stroke/transient ischemic attack (TIA) defined as sudden onset of focal or global brain, spinal cord, or retinal vascular damage, resulting in symptoms and signs of acute nervous system defects, associated with cerebral circulation disorders • Documented atrial fibrillation (AF) on the ECG performed at the screening visit • Anemia with hemoglobin ≤11 g/dL at any time during the 3-month period before or at the time of screening • Body Mass Index (BMI) ≥ 30 kg/m2 • Age ≥70 years at the time of screening
- Have stable renal function per Investigator assessment
- Subject agrees not to participate in another interventional study after signing the ICF and until the end of study (EoS) visit has been completed
What rules you out
- Patient currently enrolled into another interventional clinical trial
- Patient with a kidney transplant
- Subject has a known or suspected glomerulonephritis at the time of randomization
- Cardiogenic shock, hemodynamic instability, mechanical ventilation, intra-aortic balloon pump (IABP), left ventricular assist device (LVAD) or other forms of mechanical circulatory support (MCS), within 7 days prior to surgery
- Patient received inotropes or vasopressors within 48 hours prior to the day of surgery
- Known or suspected sepsis
- Confirmed or suspected endocarditis
- Other current active infection requiring antibiotic treatment
- Patient has severe liver disease (Child-Pugh score >7 points)
- Recently received (within the last 4 weeks) or is anticipated to receive before the end of the study chemotherapy which can interfere with kidney function (e.g. Platinum agents)
- Patient previously enrolled and randomized into this study
- Subject is scheduled for emergent surgery
- Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestate, confirmed by a positive human chorionic gonadotropin laboratory
- Known hypersensitivity to the study drug or any of its excipients
- Any medical or social condition deemed by the investigator to be likely to interfere with a patient’s ability to give informed consent, cooperate, and participate in the study or to be likely to interfere with the interpretation of the results
- Cardiac surgery planned to be performed "off-pump" without CPB
- Expected CPB duration < 60 minutes
- Body weight <50 kg; >120 kg
- Presence of AKI (KDIGO criteria) at the time of randomization
- Current, recent (within 4 weeks), or scheduled renal replacement therapy
- Patients who are post-nephrectomy
- Patients with CKD of equal or more than stage IV (GFR≤30 ml/min/1.73 m2)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.