Could a single drug shield kidneys during heart surgery?
NCT ID NCT07625553
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug R2R01 can prevent acute kidney injury in people at high risk who are having heart surgery with a heart-lung machine. Participants receive either R2R01 or a placebo before and after surgery. The goal is to see if the drug reduces kidney damage and related complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- R2R01 (a relaxin agonist)
- What this could lead to
- If successful, this could lead to a new way to prevent kidney damage after heart surgery, reducing complications and hospital stays.
- What could go wrong
- This is an early phase 2 trial, so the drug may not prove effective or safe. Possible side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 430 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCSS San Raffaele
RECRUITINGMilan, 20132, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- ICU kidney injury: does the pattern predict lasting damage?
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?