Chronic Kidney DiseaseFINERODNCT06278207
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 4 sites in 4 countries.
Trial summary
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. 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?
- Finerenone (BAY 94-8862)
- How many people
- 50,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 May 2024to 30 Sep 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: Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Asia.
Who may be able to join
- A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
- No recorded prescription for finerenone in the 12 months prior to the index date
- Age of 18 years or older as of the index date
- Evidence of T2D at any point before (and including) the index date.
- CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
- A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified
- two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
- two different eGFR test results ≥ 15 mL/min/1.73 m2 AND < 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days
Who cannot join
- Kidney failure defined as follows:
- Two different eGFR test results < 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
- Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
- A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site
- Completed
Many Locations
Multiple Locations, New Jersey, 07981
About this study
Official title: Finerenone Research of Outcomes and Drug Utilization
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.
The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (BAY 94-8862)
- 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.
Finerenone (BAY 94-8862)Drug
Also called Kerendia, Firialta
10 mg or 20 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with CKD and T2D who initiate finerenone | The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States. Receives: Drug: Finerenone (BAY 94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Sociodemographic characteristics such as age, sex, race and socio-economic status.
Measured: 12 months before first prescription/dispensation of finerenone (index date)
Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
Measured: 12 months before first prescription/dispensation of finerenone (index date)
Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.
Measured: 12 months before first prescription/dispensation of finerenone (index date)
Secondary outcomes (15)
Proportion of finerenone initiators with and without UACR measurements at baseline
UACR=Urinary Albumin-to-Creatinine Ratio
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Average UACR in the subcohort with UACR measurements
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.
Any of the following:
≥ 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days; Record of dependence on dialysis (at least 3 sessions over at least 90 days); Diagnosis records of kidney failure or CKD stage 5; Record of kidney transplant
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.
Acute myocardial infarction, identified as an inpatient hospital diagnosis of fatal or non-fatal acute myocardial infarction. Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.
Depending on the database used, this includes incidence of drug use, initiation of treatment measured by drug prescription, drug dispensation, or a combination of both depending on data availability, dosing regimen, treatment persistence and non-persistence, and implementation measured as the proportion of days covered.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Number of participants who initiate finerenone at a 10 mg dose daily
Measured: At day 0 (first prescription/dispensation of finerenone)
Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Number of participants who initiate finerenone at a 20 mg dose daily
Measured: At day 0 (first prescription/dispensation of finerenone)
Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark
Measured: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Incidence rate of hospitalization for heart failure in participants with CKD and T2D that initiate finerenone.
Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of atrial fibrillation or flutter in participants with CKD and T2D that initiate finerenone.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of hyperkalemia in participants with CKD and T2D that initiate finerenone.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of hospitalization associated with hyperkalemia in participants with CKD and T2D that initiate finerenone.
Measured: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start15 May 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278207
- Sponsor's protocol ID
- 22731
- Acronym
- FINEROD
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2024
- Last updated
- 18 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone Research of Outcomes and Drug Utilization
- ClinicalTrials.gov ID
- NCT06278207
- Acronym / sponsor ID
- FINEROD / 22731
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Feb 2024 (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 in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.
The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with CKD and T2D who initiate finerenone | – | Drug: Finerenone (BAY 94-8862)The data sources used include a network of commercial electronic health records (EHRs) and national claims data in Asia and in the United States. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Asia.
Key inclusion criteria (8 listed)
- A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
- No recorded prescription for finerenone in the 12 months prior to the index date
- Age of 18 years or older as of the index date
- Evidence of T2D at any point before (and including) the index date.
- CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
Key exclusion criteria (4 listed)
- Kidney failure defined as follows:
- Two different eGFR test results < 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;
- Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);
- A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant
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 |
|---|---|---|
| Finerenone (BAY 94-8862)Also: Kerendia, Firialta10 mg or 20 mg daily | Drug | Adult patients with CKD and T2D who initiate finerenone |
Primary outcome
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Time frame: 12 months before first prescription/dispensation of finerenone (index date)
Sociodemographic characteristics such as age, sex, race and socio-economic status.
Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Time frame: 12 months before first prescription/dispensation of finerenone (index date)
Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
Time frame: 12 months before first prescription/dispensation of finerenone (index date)
In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage, including a 15-25 ml/min/1.73 m2 eGFR subgroup.
15 secondary outcomes
Proportion of finerenone initiators with and without UACR measurements at baseline
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Average UACR in the subcohort with UACR measurements
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Number of participants who initiate finerenone at a 10 mg dose daily
Time frame: At day 0 (first prescription/dispensation of finerenone)
Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Number of participants who initiate finerenone at a 20 mg dose daily
Time frame: At day 0 (first prescription/dispensation of finerenone)
Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark
Time frame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Incidence rate of hospitalization for heart failure in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of atrial fibrillation or flutter in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of hyperkalemia in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
Incidence rate of hospitalization associated with hyperkalemia in participants with CKD and T2D that initiate finerenone.
Time frame: From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 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 18 Jun 2026.
- 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.
4 sites in 4 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 4 sites in 4 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, Japan, Taiwan. 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?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. (time frame: 12 months before first prescription/dispensation of finerenone (index date)). The study lists 3 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 18 Jun 2026.