Abstract: INFO14
Effect of Finerenone In Non-Diabetic CKD: Design of the FIND-CKD Trial In Non-Diabetic CKD: Design of the FIND-CKD Trial
Session Information
- Informational Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Diabetic Kidney Disease
- No subcategory defined
Authors
- L Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands
- Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
- Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States
- Cherney, David, University Health Network, Toronto, Ontario, Canada
- Lam, Carolyn, University Medical Center Groningen, Groningen, Netherlands
- Neuen, Brendon L., The George Institute for Global Health, Sydney, New South Wales, Australia
- Tuttle, Katherine R., Providence Washington, Seattle, Washington, United States
- Wanner, Christoph, Universitatsklinikum Wurzburg, Wurzburg, Bayern, Germany
- Brinker, Meike Daniela, Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany
- Dizayee, Sara, Regulatory Strategy Nephrology, Bayer AG, Wuppertal, Germany
- Sarwat, Samiha, Pharmaceuticals Statistics and Data Insights, Bayer U.S. LLC, Whippany, New Jersey, United States
- Vesterinen, Paula, Cardiology and Nephrology Clinical Development, Bayer AG, Espoo, Finland
- Perkovic, Vlado, The George Institute for Global Health, Sydney, New South Wales, Australia
Description
Background
Finerenone, a selective, nonsteroidal mineralocorticoid receptor antagonist (MRA), improved kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD trials. The Finerenone In Non-Diabetic Chronic Kidney Disease (FIND-CKD) trial aims to assess the efficacy and safety of finerenone, in addition to standard of care, in delaying the progression of CKD in patients with CKD without diabetes.
Methods
FIND-CKD is a randomized, double-blind, placebo-controlled, multicenter phase III trial in adults with CKD (defined as urine albumin-to-creatinine ratio ≥200–≤3500 mg/g as well as an estimated glomerular filtration rate [eGFR] ≥25–<90 mL/min/1.73 m2). Patients will be eligible if they are treated with optimized renin–angiotensin system blockade and have a serum potassium ≤4.8 mEq/L. Key exclusion criteria include a diagnosis of diabetes (or glycated hemoglobin ≥6.5%), polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasm antibodies-associated vasculitis, uncontrolled hypertension, recent or ongoing immunosuppressive therapy, or symptomatic heart failure (HF) with reduced ejection fraction. Patients will be randomized 1:1 to receive either finerenone (10 to 20 mg) or placebo once daily. The primary endpoint is the rate of change in eGFR over time (eGFR slope) from baseline to end of treatment, which is planned to be approximately 32 months. Secondary endpoints include time to the composite of: a) kidney failure, sustained eGFR decline of ≥57%, hospitalization for HF, or CV death; b) kidney failure or sustained eGFR decline of ≥57%; and c) hospitalization for HF or CV death. It is planned that 1580 patients will be randomized to provide 90% power to detect a difference in eGFR slope of 0.7 mL/min/1.73 m2 per year.
Summary
FIDELIO-DKD and FIGARO-DKD reported benefits of finerenone for kidney and CV outcomes in patients with CKD and type 2 diabetes. FIND-CKD will determine whether a cohort of patients with CKD without diabetes on optimal medical therapies experience kidney protection with finerenone.
Funding
- Bayer AG