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New treatment option for Acute Kidney Injury
Official title Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated- Acute Kidney Injury
ClinicalTrials.gov ID: NCT07625553
What this study is testing
What is R2R01?
R2R01 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, dose-ranging, double-blind, double-dummy, placebo-controlled, randomized study preceded by an open label safety run-in, in patients at high risk for Cardiac Surgery Associated - Acute Kidney Injury (CSA-AKI) following coronary artery bypass graft (CABG), valve surgery, aortic surgery, or a combination of the above, involving cardiopulmonary bypass (CPB). Subjects are eligible for screening if they are scheduled for non-emergent CABG, valve surgery, surgery of the ascending part of the aorta, or a combination of the above, involving CPB, within 4 weeks after screening.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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...
- If only one type of surgery is scheduled at least two AKI risk factors should be present
- If any combined surgery is scheduled at least one AKI risk factor should be present
You likely can't join if
- Patient currently enrolled into another treatment 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 \ 120 kg.
- Presence of AKI (KDIGO criteria) at the time of randomization.
See the full eligibility 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...
- If only one type of surgery is scheduled at least two AKI risk factors should be present
- 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 treatment 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...
- Patient currently enrolled into another treatment 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 \ 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...
- 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 assigned by chance 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.