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Open Access 28-09-2024 | Finerenone | Original Article

First interim results from FINE-REAL: a prospective, non-interventional, phase 4 study providing insights into the use and safety of finerenone in a routine clinical setting

Authors: Susanne B. Nicholas, Ricardo Correa-Rotter, Nihar R. Desai, Lixin Guo, Sankar D. Navaneethan, Kevin M. Pantalone, Christoph Wanner, Stefanie Hamacher, Samuel T. Fatoba, Andrea Horvat-Broecker, Antonio Garreta-Rufas, Alain Gay, Martin Merz, David C. Wheeler

Published in: Journal of Nephrology | Issue 8/2024

Abstract

Background

Finerenone, a selective non-steroidal mineralocorticoid receptor antagonist, improves kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The FINE-REAL study (NCT05348733) aims to evaluate the characteristics and treatment patterns of participants treated with finerenone in clinical practice.

Methods

FINE-REAL is a prospective, single-arm, non-interventional study of patients initiated on finerenone as part of their routine care in accordance with country-approved labels. The study, initiated in June 2022, is expected to be completed by January 2028. The cutoff for this pre-specified interim analysis was June 13, 2023.

Results

Participants were recruited across nephrology, endocrinology, cardiology, and primary care settings. Of 556 participants enrolled in the study by the cut-off date, 504 were included in this analysis (median follow-up duration of 7 months [finerenone treatment initiation to last recorded observation]). At baseline, 76.1% of participants were in the high or very high (KDIGO) CKD risk categories. Angiotensin converting enzyme inhibitors/angiotensin receptor blockers and sodium–glucose cotransporter 2 inhibitors were prescribed to 71.8% and 46.6% of participants, respectively. Based on prescribing information, 87.9% and 12.1% of participants initiated finerenone at doses of 10 and 20 mg, respectively. Finerenone treatment was uninterrupted in 92.3% of participants after 7 months’ median follow-up. Treatment-emergent adverse events occurred in 110 (21.8%) participants. Hyperkalemia occurred in 25 (5.0%) participants, with no cases leading to death, dialysis, or hospitalization.

Conclusion

At this interim analysis, finerenone was initiated in patients with CKD and T2D across various clinical practices participating in the study. Treatment discontinuation and hyperkalemia occurred infrequently.

Graphical abstract

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Title: First interim results from FINE-REAL: a prospective, non-interventional, phase 4 study providing insights into the use and safety of finerenone in a routine clinical setting
Authors: Susanne B. Nicholas
Ricardo Correa-Rotter
Nihar R. Desai
Lixin Guo
Sankar D. Navaneethan
Kevin M. Pantalone
Christoph Wanner
Stefanie Hamacher
Samuel T. Fatoba
Andrea Horvat-Broecker
Antonio Garreta-Rufas
Alain Gay
Martin Merz
David C. Wheeler
Publication date: 28-09-2024
Publisher: Springer International Publishing
Keywords: Finerenone
Hyperkalemia
Chronic Kidney Disease
Type 2 Diabetes
Published in: Journal of Nephrology / Issue 8/2024
Print ISSN: 1121-8428
Electronic ISSN: 1724-6059
DOI: https://doi.org/10.1007/s40620-024-02070-y

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Abstract

Background

Methods

Results

Conclusion

Graphical abstract

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