Evidence mapPaperPMID 39340711Full record

Trial reportJournal of nephrology2024

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.

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 and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Journal of nephrology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05348733 (FINE-REAL), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05348733 active not recruitingnot on this map

FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting

TypeobservationalSponsorBayerRan2022 to 2026Enrolled4,613ConditionsChronic Kidney Disease, Type 2 Diabetes MellitusArmsKerendia (Finerenone, BAY94-8862)
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Susanne B NicholasDepartment of Medicine, Division of Nephrology, David Geffen School of Medicine at University of California, Los Angeles, 7-155 Factor Bldg, 10833 LeConte Blvd, Los Angeles, CA, 90095, USA. SuNicholas@mednet.ucla.edu.ORCID 0000-0003-3535-9120
Ricardo Correa-RotterDepartment of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Nihar R DesaiSection of Cardiovascular Medicine, Yale School of Medicine, Yale New Haven Hospital, New Haven, CT, USA.
Lixin GuoDepartment of Endocrinology, Institute of Geriatric Medicine, Beijing Hospital, National Center of Gerontology, Chinese Academy of Sciences, Beijing, China.
Sankar D NavaneethanSection of Nephrology, Baylor College of Medicine, Houston, TX, USA.
Kevin M PantaloneEndocrinology and Metabolism Institute, Cleveland Clinic, Cleveland, OH, USA.
Christoph WannerDepartment of Clinical Research and Epidemiology, Comprehensive Heart Failure Center, University Hospital Würzburg, Würzburg, Germany.
Stefanie HamacherClinStat GmbH, Huerth, Germany.
Samuel T FatobaMedical Affairs, Bayer U.S. LLC, Whippany, NJ, USA.
Andrea Horvat-BroeckerMedical Affairs & Pharmacovigilance, Bayer AG, Wuppertal, Germany.
Antonio Garreta-RufasMedical Affairs Cardio-Renal, Pharmaceuticals, Bayer Vital GmbH, Leverkusen, Germany.
Alain GayMedical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany.
Martin MerzMedical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany.
David C WheelerDepartment of Renal Medicine, University College London, London, UK.

Funding

Yale Clinical and Translational Science AwardUL1TR001863 · YALE UNIVERSITY · 2025 to 2025
$9.9M
UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES)P50MD017366 · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2025 to 2025
$3.3M
Prediction of Chronic Kidney Disease by Simulation Modeling to Improve the Health of Minority PopulationsR01MD014712 · NIMHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ALEX BUI, Susanne B Nicholas · 2022 to 2023
$749k
Network CoreU2CDK129496 · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2025 to 2025
$460k
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS U2C DK129496NIMHD NIH HHS P50 MD017366NIMHD NIH HHS R01 MD014712
6 · The paper itself

Abstract

backgroundFinerenone, 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.

methodsFINE-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.

resultsParticipants 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.

conclusionAt 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.

Indexed as

Diabetes Mellitus, Type 2Mineralocorticoid Receptor AntagonistsNaphthyridinesRenal Insufficiency, ChronicAgedDiabetic NephropathiesFemaleHumansHyperkalemiaMaleMiddle AgedProspective StudiesTreatment OutcomefinerenoneMineralocorticoid Receptor AntagonistsNaphthyridinesChronic kidney diseaseFinerenoneNon-interventional studyType 2 diabetes

Identifiers

PMID39340711
PMCPMC11649709

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.