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A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05348733
Enrollment
4613
Registered
2022-04-27
Start date
2022-06-13
Completion date
2026-12-22
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Type 2 Diabetes Mellitus

Brief summary

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: * Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants * Reasons for starting finerenone * Reasons for stopping finerenone early * How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) * Dosing of finerenone * Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: * Stopping finerenone treatment too early * Dialysis (a medical procedure to filter the blood of extra water and waste) * Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

Interventions

Decision will taken by the treating physician to initiate treatment with finerenone.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult participants of all genders (≥18 years old) * Diagnosis of CKD associated with T2D based on assessment by physician. * Treatment according to local marketing authorization, finerenone 20 or 10 mg.Treatment should have been started up to 8 weeks before or after the ICF is signed. * Decision to initiate treatment with finerenone must be made before ICF is signed. * Signed informed consent

Exclusion criteria

* Participation in an investigational trial at any time during the course of this study * Contra-indications according to the local label.

Design outcomes

Primary

MeasureTime frame
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).Approximately 62 months
Descriptive summary of reasons for introducing finerenone.Approximately 62 months
Descriptive summary of reasons for discontinuation of finerenone.Approximately 62 months
Planned and actual duration of treatment with finerenoneApproximately 62 months
Planned and actual daily dose of finerenone treatmentApproximately 62 months
Planned and actual frequency of finerenone treatmentApproximately 62 months
Descriptive summary of secondary therapies used in participants with CKD and T2D.Approximately 62 months

Secondary

MeasureTime frameDescription
Occurrence of adverse events (AEs) and serious adverse events (SAEs)Approximately 62 months
Occurrence of hyperkalemiaApproximately 62 monthsleading to permanent study drug discontinuation, dialysis or hospitalization

Countries

Argentina, Belgium, Brazil, Canada, China, Denmark, Germany, Greece, Mexico, Netherlands, Portugal, Saudi Arabia, Singapore, Slovenia, South Korea, Switzerland, Taiwan, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026