Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated- Acute Kidney Injury

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. In addition, subjects are eligible if AKI risk factors are present (at screening): a. If isolated surgery (CABG, single valve surgery, or of the ascending part of the aorta surgery) is scheduled, at least two AKI risk factors should be present b. If combined surgery is scheduled, at least one AKI risk factor should be present Risk factors for AKI are defined below: • Chronic kidney disease (CKD) stage III • 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 * 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/tran…

This description comes directly from the study's public registry record.

Minh Nguyêt Duong, MD  ·  +316 28 44 33 89  ·  mnduong@narrowrivermgmt.com

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