Chronic Kidney DiseaseNCT07232537
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
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Kerendia (Finerenone, BAY94-8862)
- How many people
- 529 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2025to 28 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Participation in an investigational trial at any time during the course of this study
- Contra-indications according to the local label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Kerendia (Finerenone, BAY94-8862)
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerendia (Finerenone, BAY94-8862)Drug
Decision will be taken by the treating physician to initiate treatment with finerenone.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with CKD and T2D | Participants who are newly prescribed finerenone under routine treatment conditions. Receives: Drug: Kerendia (Finerenone, BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes (T2D)
Measured: Up to 12 months after start of finerenone
Descriptive summary of reasons for introducing finerenone
Measured: Up to 12 months after start of finerenone
Descriptive summary of reasons for discontinuation of finerenone
Measured: Up to 12 months after start of finerenone
Planned and actual duration of treatment with finerenone
Measured: Up to 12 months after start of finerenone
Planned and actual dosing of finerenone
Measured: Up to 12 months after start of finerenone
Descriptive summary of secondary therapies used in participants with CKD and T2D
Measured: Up to 12 months after start of finerenone
Secondary outcomes (2)
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)
Measured: Up to 30 days after the final treatment with finerenone
Occurrence of hyperkalemia
Reported hyperkalemia leading to permanent study drug discontinuation, dialysis or hospitalization
Measured: Up to 30 days after the final treatment with finerenone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232537
- Sponsor's protocol ID
- 23104
- Status last verified
- 6 Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINE-REAL Korea: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting in Korea
- ClinicalTrials.gov ID
- NCT07232537
- Acronym / sponsor ID
- 23104
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 529 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with CKD and T2D | – | Drug: Kerendia (Finerenone, BAY94-8862)Participants who are newly prescribed finerenone under routine treatment conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in an investigational trial at any time during the course of this study
- Contra-indications according to the local label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kerendia (Finerenone, BAY94-8862)Decision will be taken by the treating physician to initiate treatment with finerenone. | Drug | Participants diagnosed with CKD and T2D |
Primary outcome
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes (T2D)
Time frame: Up to 12 months after start of finerenone
Descriptive summary of reasons for introducing finerenone
Time frame: Up to 12 months after start of finerenone
Descriptive summary of reasons for discontinuation of finerenone
Time frame: Up to 12 months after start of finerenone
Planned and actual duration of treatment with finerenone
Time frame: Up to 12 months after start of finerenone
Planned and actual dosing of finerenone
Time frame: Up to 12 months after start of finerenone
Descriptive summary of secondary therapies used in participants with CKD and T2D
Time frame: Up to 12 months after start of finerenone
2 secondary outcomes
Occurrence of adverse events (AEs)
Time frame: Up to 30 days after the final treatment with finerenone
Occurrence of hyperkalemia
Time frame: Up to 30 days after the final treatment with finerenone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes (T2D) (time frame: Up to 12 months after start of finerenone). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.