Chronic Kidney DiseaseNCT05348733
A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 56 sites in 19 countries.
Trial 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. 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
- 4,613 participants
- Where
- 56 sitesin 19 countries
- Study dates
- 13 Jun 2022to 22 Dec 2026
- 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 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
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
56 sites in 19 countries.
56 sites in 19 countries
United States38 sites
Augusta University
Augusta, Georgia, 30912
University of Maryland Midtown Professionals Group Healthcare
Baltimore, Maryland, 21201
Coastal Medical Research
Brunswick, Georgia, 31523
Gaffney Health Services
Charlotte, North Carolina, 28205
Medico
Chicago, Illinois, 60616
The EnLyv Clinics
Edison, New Jersey, 08820
Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721
AA Medical Research Center
Flint, Texas, 48504
Kidney Disease Medical Group
Glendale, California, 91206
Renal Consultants Medical Group
Granada Hills, California, 91344
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546
Bland Clinic
Greensboro, North Carolina, 27401
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432
Nephrology Associates Northern Illinois and Indiana
Hinsdale, Illinois, 60521
Laurie Tom, MD
Honolulu, Hawaii, 96813
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96813
Clinical Research Stategies Inc
Houston, Texas, 77090
Nephrology Consultants LLC
Huntsville, Alabama, 35805
RGV Endocrine Center
McAllen, Texas, 78503
DarSalud Care / LifeDOC Research
Memphis, Tennessee, 38119
Care Access Research - Minneapolis
Minneapolis, Minnesota, 55403
University of Central Florida College of Medicine
Orlando, Florida, 32817
AKDHC Medical Research Servies LLC
Phoenix, Arizona, 85016
Dallas Renal Group
Plano, Texas, 75093
Gulf View Medical
Port Charlotte, Florida, 33952
Hanson Clinical Research Center
Port Charlotte, Florida, 33952
Panoramic Health
Providence, Rhode Island, 02904
Renown Regional Medical Center
Reno, Nevada, 89502
Ochsner Medical Foundation
Slidell, Louisiana, 70461
Caritas Medical Center
Stockbridge, Georgia, 30281
Herman Clinical Research LLC
Suwanee, Georgia, 30024
MultiCare Endocrinology Specialists Tacoma
Tacoma, Washington, 98405
Kidney and Hypertension Center of Wabash Valley LLC
Terre Haute, Indiana, 47804
Nephrology and Hypertension Associates
Tupelo, Mississippi, 38801
Tranquil Clinical Research
Webster, Texas, 77598
Metabolic Research Institute
West Palm Beach, Florida, 33401
Ardmore Medical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting
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.
Read more
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.
- 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 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: Approximately 62 months
Descriptive summary of reasons for introducing finerenone.
Measured: Approximately 62 months
Descriptive summary of reasons for discontinuation of finerenone.
Measured: Approximately 62 months
Planned and actual duration of treatment with finerenone
Measured: Approximately 62 months
Planned and actual daily dose of finerenone treatment
Measured: Approximately 62 months
Planned and actual frequency of finerenone treatment
Measured: Approximately 62 months
Descriptive summary of secondary therapies used in participants with CKD and T2D.
Measured: Approximately 62 months
Secondary outcomes (2)
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Approximately 62 months
Occurrence of hyperkalemia
leading to permanent study drug discontinuation, dialysis or hospitalization
Measured: Approximately 62 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start13 Jun 2022
- Primary completion28 Sep 2026
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 4,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348733
- Sponsor's protocol ID
- 21785
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. 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. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.
PubMed 41196655Desai NR, Navaneethan SD, Nicholas SB, Pantalone KM, Wanner C, Hamacher S, Gay A, Wheeler DC. Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. J Diabetes Complications. 2023 Apr;37(4):108411. doi: 10.1016/j.jdiacomp.2023.108411. Epub 2023 Feb 2.
PubMed 36857997
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FINE-REAL: A Non-interventional Study Providing Insights Into the Use of Finerenone in a Routine Clinical Setting
- ClinicalTrials.gov ID
- NCT05348733
- Acronym / sponsor ID
- 21785
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,613 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 27 Apr 2022 (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 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.
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 (5 listed)
- 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
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 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: Approximately 62 months
Descriptive summary of reasons for introducing finerenone.
Time frame: Approximately 62 months
Descriptive summary of reasons for discontinuation of finerenone.
Time frame: Approximately 62 months
Planned and actual duration of treatment with finerenone
Time frame: Approximately 62 months
Planned and actual daily dose of finerenone treatment
Time frame: Approximately 62 months
Planned and actual frequency of finerenone treatment
Time frame: Approximately 62 months
Descriptive summary of secondary therapies used in participants with CKD and T2D.
Time frame: Approximately 62 months
2 secondary outcomes
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Approximately 62 months
Occurrence of hyperkalemia
Time frame: Approximately 62 months
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 16 Oct 2026.
- Derived from this study: PubMed 41196655Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.
- Derived from this study: PubMed 36857997Desai NR, Navaneethan SD, Nicholas SB, Pantalone KM, Wanner C, Hamacher S, Gay A, Wheeler DC. Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. J Diabetes Complications. 2023 Apr;37(4):108411. doi: 10.1016/j.jdiacomp.2023.108411. Epub 2023 Feb 2.
- Individual participant dataSharing planned: No. 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 scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. 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. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information 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.
56 sites in 19 countries: 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 56 sites in 19 countries.
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 5 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 16 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 56 sites in United States, Argentina, Belgium, Brazil, Canada and 14 more countries. 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: Approximately 62 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348733, which also lists 2 linked publications.
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 16 Oct 2026.