Chronic Kidney DiseaseFINEXPLORERNCT07554469
An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in Spain.
Trial summary
This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed. Chronic kidney disease (CKD) is common in people with type 2 diabetes. 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 (Kerendia, BAY94-8862)
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2026to 31 May 2029
- 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
- Patients who sign the written informed consent to participate in the study.
- Men or women aged ≥18 years.
- Patients with CKD associated with type 2 diabetes and albuminuria (UACR >30 mg/g).
- Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.
Who cannot join
- eGFR < 25 mL/min/1.73 m².
- Severe hepatic impairment.
- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.
- Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
- Uncontrolled arterial hypertension (mean sitting systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg at inclusion).
- Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain
This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.
Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.
Read more
The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.
Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.
The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:
- Clinical characteristics of participants, including their medical history related to CKD and T2D.
- Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).
- Participants' glucose, hemoglobin and potassium levels.
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.
Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Being tested
- Finerenone (Kerendia, BAY94-8862)
- Keywords
- Finerenone, Chronic Kidney Disease, Type 2 Diabetes Mellitus
- 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 (Kerendia, 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: Finerenone (Kerendia, BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Secondary outcomes (26)
Percentage of patients who show an improvement in the Klinrisk model score after 12 months of treatment with finerenone.
Measured: Up to 12 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Time to the composite endpoint of renal outcomes.
Composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for kidney failure.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained decrease in eGFR to <15 mL/min/1.73 m2 maintained for at least 4 weeks.
eGFR = estimated glomerular filtration rate.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained ≥40% eGFR decline from baseline maintained for at least 4 weeks.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of KRT.
KRT = kidney replacement therapy.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from renal causes.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Change in UACR at months 6, 12, 18 and 24 (> 30%, 40% or >50%)
UACR = urinary albumin-to-creatinine ratio
Measured: At months 6, 12, 18 and 24.
Change in eGFR chronic slope at months 6, 12, 18 and 24.
Measured: At months 6, 12, 18 and 24.
Levels of NT-proBNP values.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of death from CV causes, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from CV causes.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal myocardial infarction.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal stroke.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of hospitalizations for heart failure.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of death from CV causes.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal myocardial infarction.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal stroke.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of hospitalization for heart failure.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Number of adverse events (AEs) that occur during the study period.
Measured: Up to 30 days after the final treatment with finerenone.
Number of discontinuations of finerenone for AEs.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Number of hospitalizations for AEs.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients with hypokalemia, normokalemia and hyperkalemia.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients who maintain normokalemia over the entire follow-up.
This endpoint will be analysed in patients with normokalemia at the start of finerenone.
Measured: Up to 24 months from the beginning of treatment with finerenone.
Incidence of acute kidney injury (AKI) requiring hospitalization.
Measured: Up to 24 months from the beginning of 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 posted28 Apr 2026
- Study start26 May 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554469
- Sponsor's protocol ID
- 23098
- Acronym
- FINEXPLORER
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2026
- Last updated
- 14 Oct 2026
- Results posted
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain
- ClinicalTrials.gov ID
- NCT07554469
- Acronym / sponsor ID
- FINEXPLORER / 23098
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Keywords
- Finerenone, Chronic Kidney Disease, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 28 Apr 2026 (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 a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.
Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.
The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.
Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.
The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:
- Clinical characteristics of participants, including their medical history related to CKD and T2D.
- Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).
- Participants' glucose, hemoglobin and potassium levels.
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.
Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with CKD and T2D | – | Drug: Finerenone (Kerendia, 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)
- Patients who sign the written informed consent to participate in the study.
- Men or women aged ≥18 years.
- Patients with CKD associated with type 2 diabetes and albuminuria (UACR >30 mg/g).
- Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.
Key exclusion criteria (6 listed)
- eGFR < 25 mL/min/1.73 m².
- Severe hepatic impairment.
- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.
- Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
- Uncontrolled arterial hypertension (mean sitting systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg at inclusion).
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 (Kerendia, BAY94-8862)Decision will be taken by the treating physician to initiate treatment with finerenone. | Drug | Participants diagnosed with CKD and T2D |
Primary outcome
Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
26 secondary outcomes
Percentage of patients who show an improvement in the Klinrisk model score after 12 months of treatment with finerenone.
Time frame: Up to 12 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Time to the composite endpoint of renal outcomes.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for kidney failure.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained decrease in eGFR to <15 mL/min/1.73 m2 maintained for at least 4 weeks.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) for sustained ≥40% eGFR decline from baseline maintained for at least 4 weeks.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of KRT.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from renal causes.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Change in UACR at months 6, 12, 18 and 24 (> 30%, 40% or >50%)
Time frame: At months 6, 12, 18 and 24.
Change in eGFR chronic slope at months 6, 12, 18 and 24.
Time frame: At months 6, 12, 18 and 24.
Levels of NT-proBNP values.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of the composite outcome of death from CV causes, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of death from CV causes.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal myocardial infarction.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of nonfatal stroke.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Cumulative incidence (%) of hospitalizations for heart failure.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of death from CV causes.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal myocardial infarction.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of nonfatal stroke.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Incidence rate of hospitalization for heart failure.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Number of adverse events (AEs) that occur during the study period.
Time frame: Up to 30 days after the final treatment with finerenone.
Number of discontinuations of finerenone for AEs.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Number of hospitalizations for AEs.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients with hypokalemia, normokalemia and hyperkalemia.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Percentage of patients who maintain normokalemia over the entire follow-up.
Time frame: Up to 24 months from the beginning of treatment with finerenone.
Incidence of acute kidney injury (AKI) requiring hospitalization.
Time frame: Up to 24 months from the beginning of 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 14 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.
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 Spain.
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 6 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 14 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 Spain. 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?
Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone. (time frame: Up to 24 months from the beginning of treatment with finerenone.). 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 14 Oct 2026.