Abstract: INFO06-FR
Rationale and Design of a Phase 3 Registration Trial Investigating Finerenone in Participants with CKD and Type 1 Diabetes Using a Urine Albumin-Creatinine Ratio (UACR) End Point (FINE-ONE)
Session Information
- Informational Posters - II
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- No subcategory defined
Authors
- Heerspink, Hiddo Jan L., Clinical Pharmacy and Pharmacology, University of Groningen University Medical Center Groningen, Groningen, Netherlands
- Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
- Groop, Per-Henrik, Department of Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
- Colhoun, Helen, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom
- Lawatscheck, Robert, Clinical Research, Bayer AG, Berlin, Germany
- Scott, Charlie, Data Science and Analytics, Bayer PLC, Reading, United Kingdom
- McGill, Janet B., Metabolism & Lipid Research, Washington University in St. Louis, School of Medicine, St. Louis, Missouri, United States
Description
CKD affects up to 40% of people with T1D. Despite guideline-recommended RAS inhibition, 25% of people with T1D and CKD still progress to kidney failure. CKD is a leading cause of mortality in T1D and represents an area of unmet need. Finerenone, a nonsteroidal MRA, is approved for the treatment of CKD in T2D. It is assumed that finerenone can demonstrate benefits on kidney outcomes in CKD associated with T1D.
FINE-ONE (NCT05901831) is a global, randomized, placebo-controlled, double-blind Phase 3 registration trial of 7.5 months’ duration in ~220 adults with T1D, UACR of ≥200–5000 mg/g and eGFR of 25–90 mL/min/1.73 m2. Regulators acknowledge the use of UACR as a bridging biomarker for kidney outcomes to support approval and registration of finerenone in T1D, provided all necessary criteria are met. UACR is an appropriate bridging biomarker endpoint as it meets set criteria including (1) its use in a small target population with no approved interventions, (2) the similar role of UACR in the pathophysiology of CKD in diabetes, (3) the epidemiological evidence demonstrating the association between a decrease in albuminuria and reductions in kidney outcomes in diabetes and (4) finerenone’s demonstrable benefit-to-risk profile in individuals with CKD associated with T2D in a large, high-quality dataset. In CKD associated with T2D, a substantial proportion of finerenone’s treatment effect on kidney outcomes was explained by UACR reduction. The primary objective of FINE-ONE is to demonstrate that finerenone in addition to SOC is superior to placebo in reducing UACR.
The primary outcome is the relative change in UACR from baseline over 6 months (Figure). Secondary outcomes are the incidences of TEAEs, TESAEs and hyperkalemia.
The FINE-ONE Phase 3 study will evaluate the efficacy and safety of finerenone in CKD associated with T1D. Finerenone could become a new registered treatment for slowing kidney disease progression in CKD associated with T1D.
Funding
- The FINE-ONE study is supported by Bayer AG. Medical writing support was provided by Moamen Hammad, PhD, and editorial support, including formatting, proofreading, and submission, was provided by Melissa Ward, BA, both of Scion, London, UK, supported by Bayer according to Good Publication Practice guidelines (https://www.acpjournals.org/doi/10.7326/M22-1460).