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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Kerendia (Finerenone, BAY94-8862)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female or male patient (≥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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants diagnosed with CKD and T2D<br>Participants who are newly prescribed finerenone under routine treatment conditions. | Drug: Kerendia (Finerenone, BAY94-8862)<br>* Decision will taken by the treating physician to initiate treatment with finerenone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 finerenone |  | Approximately 62 months | 
| Planned and actual daily dose of finerenone treatment |  | Approximately 62 months | 
| Planned and actual frequency of finerenone treatment |  | Approximately 62 months | 
| Descriptive summary of secondary therapies used in participants with CKD and T2D. |  | Approximately 62 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) |  | Approximately 62 months | 
| Occurrence of hyperkalemia | leading to permanent study drug discontinuation, dialysis or hospitalization | Approximately 62 months |