Abstract: FR-PO980
Design and Baseline Characteristics of the FIND-CKD Trial: Efficacy of Finerenone on Kidney Disease Progression in People with Non-Diabetic CKD
Session Information
- CKD Interventions: Trials and Quality Improvement
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Heerspink, Hiddo Jan L., 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 S.P., National Heart Centre Singapore and Duke-National University of Singapore, Singapore, Singapore
- Neuen, Brendon Lange, 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 Cardiology and Nephrology, Bayer AG, Wuppertal, Germany
- Kolkhof, Peter, Preclinical Research Cardiovascular, Research and Development, Bayer AG, Wuppertal, Germany
- Schloemer, Patrick, Statistics & Data Insights, Bayer AG, Berlin, Germany
- Vesterinen, Paula Hannele, Cardiology and Nephrology Clinical Development, Bayer AG, Espoo, Finland
- Perkovic, Vlado, The George Institute for Global Health, Sydney, New South Wales, Australia
Group or Team Name
- On Behalf of the FIND-CKD Steering Committee and Investigators.
Background
Finerenone, a selective, nonsteroidal mineralocorticoid receptor antagonist, improved kidney and cardiovascular (CV) outcomes in people with CKD and type 2 diabetes (T2D) in two phase 3 outcome trials. However, CKD is due to non-diabetic etiologies in most people across many parts of the world. The effects of finerenone on kidney outcomes in people with CKD without diabetes are being investigated in the FIND-CKD trial (NCT05047263 and EudraCT: 2021-000421-27).
Methods
FIND-CKD is a randomized, double-blind, and placebo-controlled phase 3 trial for people with CKD of non-diabetic etiology. People with a urine albumin-to-creatinine ratio of ≥200–≤3500 mg/g and estimated glomerular filtration rate (eGFR) ≥25–<90 ml/min/1.73 m2 at screening are randomized 1:1 to once daily 10 or 20 mg finerenone or placebo on top of optimized renin-angiotensin system blockade. The primary efficacy outcome is total eGFR slope, defined as the mean annual rate of change in eGFR from baseline to month 32. Secondary efficacy outcomes include a combined cardiorenal composite outcome comprising time to kidney failure, sustained ≥57% decrease in eGFR, hospitalization for heart failure or CV death, as well as separate kidney and CV composite outcomes. Adverse events are recorded to assess tolerability and safety.
Results
The FIND-CKD trial will study the efficacy and safety of finerenone in people with non-diabetic causes of CKD at high risk of disease progression. The first patient was enrolled in September 2021 and patient enrolment completed in May 2023. Baseline clinical characteristics and demographics will be presented.
Conclusion
FIND-CKD is the first phase 3 trial of finerenone in people with CKD of non-diabetic etiology. This trial will determine the potential expanded role for finerenone for the treatment of CKD beyond T2D.
Funding
- Commercial Support – The study and this analysis were funded by Bayer AG, Wuppertal, Germany. Medical writing and/or editorial assistance was provided by Charlotte Simpson, PhD, and Melissa Ward, BA, both of Scion, London, UK. This assistance was funded by Bayer AG, Wuppertal Germany according to Good Publication Practice guidelines.