Relaxin agonist R2R01 in high-risk heart-surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, dose-ranging, randomized trial with a placebo control and double-dummy design, preceded by an open-label safety run-in. Eligible adults scheduled for non-emergency CABG, valve, ascending aorta, or combinations with CPB and who have AKI risk factors will be randomly assigned to receive R2R01 at varying doses or placebo. The study aims to determine safety and the potential kidney-protective effect of R2R01 during perioperative care. Primary outcomes focus on incidence and severity of CSA-AKI, with secondary assessments including renal function biomarkers and safety signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. If only one type of surgery is scheduled at least two AKI risk factors should be present
  2. If any combined surgery is scheduled at least one AKI risk factor should be present
* 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.
* Both female patients, as well as female partners of male patients who are of childbearing potential must be willing to not become pregnant for the complete duration of the study until 90 days after the last dose of study drug.

Exclusion Criteria:

* Patient currently enrolled into another interventional clinical trial.
* Subject is scheduled for emergent surgery.
* 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, prior, 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).
* 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).
* Preoperative frailty (impaired mobility defined as patients requiring a wheelchair; and severe malnutrition defined as BMI \<16 kg/m²).
* Patient previously enrolled and randomized into this study.
* 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.
* Patient who is in a relationship of dependency with the sponsor, investigator or trial site, or committed to an institution by virtue of an order issued by judicial or administrative authorities.

Where it's running

• IRCSS San Raffaele
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Minh Nguyêt Duong, MD
• Email: mnduong@narrowrivermgmt.com
• Phone: +316 28 44 33 89

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.