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NCT06278207: FINEROD

An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Recruiting now Last updated 31 March 2026
What this trial tests

trial testing Finerenone (BAY 94-8862) in Chronic Kidney Disease in 50,000 participants. Currently enrolling.

Timeline
15 May 2024
Primary endpoint
30 September 2026
30 September 2026

Quick facts

Lead sponsorBayer
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment50,000
Start date15 May 2024
Primary completion30 September 2026
Estimated completion30 September 2026
Sites4 locations across Taiwan, Japan, United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Chronic Kidney Disease or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Early Clinical Experience of Finerenone in People with Chronic Kidney Disease and Type 2 Diabetes in Japan-A Multi-Cohort Study from the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) Platform.
    Sato A, Rodriguez-Molina D, Yoshikawa-Ryan K, Yamashita S, et al · · 2024 · cited 9× · PMID 39274317 · DOI 10.3390/jcm13175107
  2. FOUNTAIN: a modular research platform for integrated real-world evidence generation.
    Oberprieler NG, Pladevall-Vila M, Johannes C, Layton JB, et al · · 2024 · cited 8× · PMID 39354358 · DOI 10.1186/s12874-024-02344-w
  3. Finerenone: Potential Clinical Application Across the Spectrum of Cardiovascular Disease and Chronic Kidney Disease.
    Haq N, Uppal P, Abedin T, Lala A. · · 2025 · cited 1× · PMID 40364247 · DOI 10.3390/jcm14093213
  4. What to do with key cardiovascular drugs when kidney function worsens?
    Bergen K, Spaak J. · · 2026 · PMID 41531854 · DOI 10.1093/ckj/sfaf354

Verify or expand the search:

Other trials of Finerenone (BAY 94-8862)

Trials testing the same drug.

Other recruiting trials for Chronic Kidney Disease

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06278207.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing