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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.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523037-25-00
Enrollment
390
Registered
2026-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic surgery, involving cardiopulmonary bypass (CPB)., or a combination of the above, Patients at high risk for Cardiac Surgery Associated – Acute Kidney Injury (CSA-AKI) following coronary artery bypass graft (CABG), valve surgery

Brief summary

Proportion of subjects developing AKI within 7 days after start of on-pump cardiac surgery based on SCr (AKI of any stage according to KDIGO criteria, see above), Nature, frequency and severity of treatment-emergent adverse events (TEAEs).

Detailed description

Severity grade of AKI within 7 days after start of cardiac surgery based on SCr (according to KDIGO criteria, see above)., Duration of AKI defined as the number of days meeting the definition of AKI (according to KDIGO criteria, see above)., Change in SCr and cystatin C (and corresponding eGFR values) at postoperative hours 12, 24, 48, 72, and postoperative Days 7 and 30, versus baseline, Proportion of subjects with a major adverse kidney event (MAKE) defined as all-cause mortality, RRT and/or ≥ 25% sustained reduction of kidney function (i.e., a reduction of eGFR of 25% or more compared to the baseline pre-surgery sample, using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equations (with either SCr, CyC, or both) at postoperative Day 7 and at postoperative Day 30, Length of ICU stay (in hours) defined as the duration of stay in the ICU immediately following surgery (or recovery room post-surgery) until ICU discharge, Length of Hospital stay (in days) defined as the duration of stay in the hospital from the day of surgery to hospital discharge, ICU free days and hospital free days, Proportion of subjects readmitted to the hospital at postoperative Day 30

Interventions

Sponsors

River 2 Renal Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of subjects developing AKI within 7 days after start of on-pump cardiac surgery based on SCr (AKI of any stage according to KDIGO criteria, see above), Nature, frequency and severity of treatment-emergent adverse events (TEAEs).

Secondary

MeasureTime frame
Severity grade of AKI within 7 days after start of cardiac surgery based on SCr (according to KDIGO criteria, see above)., Duration of AKI defined as the number of days meeting the definition of AKI (according to KDIGO criteria, see above)., Change in SCr and cystatin C (and corresponding eGFR values) at postoperative hours 12, 24, 48, 72, and postoperative Days 7 and 30, versus baseline, Proportion of subjects with a major adverse kidney event (MAKE) defined as all-cause mortality, RRT and/or ≥ 25% sustained reduction of kidney function (i.e., a reduction of eGFR of 25% or more compared to the baseline pre-surgery sample, using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equations (with either SCr, CyC, or both) at postoperative Day 7 and at postoperative Day 30, Length of ICU stay (in hours) defined as the duration of stay in the ICU immediately following surgery (or recovery room post-surgery) until ICU discharge, Length of Hospital stay (in days) defined as the

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 5, 2026