An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea

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

This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied.

Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D.

The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D.

Finerenone is a medication that works by blocking certain proteins known as 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.

The main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea.

The FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population.

To achieve this, researchers will collect data on:

• Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health.
• Reasons for starting finerenone.
• Reasons for stopping finerenone early.
• The planned and actual duration of finerenone treatment.
• The dosing of finerenone.
• Other medications taken alongside finerenone.

The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.

One specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to:

• Early discontinuation of finerenone treatment.
• The need for dialysis, a procedure that filters waste from the blood.
• Hospitalization for care.

Data for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits.

Participants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Kerendia (Finerenone, BAY94-8862)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• South Korea
  • Multiple Locations, South Korea
    • Recruiting
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosed of CKD and T2D will be enrolled after the decision for treatment with finerenone has been made by the treating physician.

Description

Inclusion Criteria:

• Adult female or male participant - 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants diagnosed with CKD and T2D; Participants who are newly prescribed finerenone under routine treatment conditions.	Drug: Kerendia (Finerenone, BAY94-8862); Decision will be taken by the treating physician to initiate treatment with finerenone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes (T2D)	Up to 12 months after start of finerenone
Descriptive summary of reasons for introducing finerenone	Up to 12 months after start of finerenone
Descriptive summary of reasons for discontinuation of finerenone	Up to 12 months after start of finerenone
Planned and actual duration of treatment with finerenone	Up to 12 months after start of finerenone
Planned and actual dosing of finerenone	Up to 12 months after start of finerenone
Descriptive summary of secondary therapies used in participants with CKD and T2D	Up to 12 months after start of finerenone

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AEs)	Including treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), unexpected AEs, unexpected ADRs, serious adverse events (SAEs), and serious adverse drug reactions (SADRs)	Up to 30 days after the final treatment with finerenone
Occurrence of hyperkalemia	Reported hyperkalemia leading to permanent study drug discontinuation, dialysis or hospitalization	Up to 30 days after the final treatment with finerenone

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; finerenone
• Other Study ID Numbers: 23104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No