Type 2 Diabetes Mellitus (T2DM)Phase 4FineCaReNCT07026539
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
A Phase 4 study testing Finerenone (BAY 94-8862) in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial summary
The global prevalence of diabetes is increasing substantially. Around 40 % of patients with type 2 diabetes develop chronic kidney disease. Diabetic kidney disease is the leading cause of kidney failure, it is closely linked to cardiovascular disease and heart failure and is associated with a threefold increase in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Finerenone (BAY 94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Oct 2024to 30 Apr 2028
- Phase
- Phase 4
- 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
Who may be able to join
- Age above 18 years.
- Diagnosis of type 2 diabetes according to the World Health Organization definition.
- Current treatment with a SGLT2-I1 at maximally tolerated dose.
- Current treatment with an ACE inhibitor or an ARB1 at maximally tolerated dose.
- Plasma potassium level of 4.8 mmol/L or less at the time of screening.
- CKD defined as eGFR ≥25 ml/min/1.73 m2 and albuminuria (UACR between 30-5000 mg/g).
- Speak and understand Danish fluently.
Who cannot join
- Inability to give informed consent.
- Severe renal disease with eGFR <25 ml/min/1.73m2.
- Severe hepatic disease (plasma ALAT above 3 x upper limit of normal).
- Active cancer diagnosis other than basal cell carcinoma.
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
Show all 17Show fewer
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
- Chronic or acute pancreatitis.
- Pregnancy or breastfeeding (see pregnancy below).
- Poorly controlled medical condition, e.g. congestive heart failure (New York Heart Association III-IV or EF ≤ 40%), recent (within 3 months) stroke or acute myocardial infarction or any other condition that in the opinion of the investigator will put the trial participant at risk if participating in the trial.
- Allergy to finerenone or any of the excipients contained in the drug.
- Current systemic treatment with strong inhibitors of CYP3A4 (e.g. itraconazol, ketoconazole, ritonavir, cobicistat, clarithromycin) or strong inducers of CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital).
- Current treatment with other MRAs (e.g. spironolactone, eplerenone etc.).
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
- Addison's disease.
- Contraindications to MRI.
- Previous renal or heart transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Per L Poulsen, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus N, 8200
Lene Halkjær, MD, +4528928399, lene.halkjaer@clin.au.dk
Anna Dons-Jensen, MD, +4525723131, adj@clin.au.dk
About this study
Official title: Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes - A Randomized Trial
The global prevalence of diabetes is increasing substantially. Around 40 % of patients with type 2 diabetes develop chronic kidney disease. Diabetic kidney disease is the leading cause of kidney failure, it is closely linked to cardiovascular disease and heart failure and is associated with a threefold increase in all-cause mortality and a 16-year loss in life expectancy.
In large clinical trials, the novel drug finerenone has shown to lower the risk of chronic kidney disease progression and improve the cardiovascular outcome for patients with type 2 diabetes and chronic kidney disease. However these trials did not not reflect current standard-of-care for patients with type 2 diabetes and chronic kidney disease, as only a minority (6.7 %) received an SGLT2-I - a treatment that has been considered standard-of-care for these patients since 2022.
Read more
The FineCaRe study aims to investigate the effect of treatment with finerenone in combination with an SGLT2-I on albuminuria and left ventricular mass in patients with type 2 diabetes and chronic kidney disease.
The investigators will perform a 26-week investigator-initiated, single-center, placebo-controlled, double-blinded randomized clinical trial. After screening and inclusion, participants will be randomized 1:1 to either finerenone or placebo treatment. Outcomes will be assessed at baseline, during and after 26 weeks of treatment.
The primary goal of the FineCaRe study is to acquire new knowledge that may help in preventing kidney failure in diabetic patients. With this project the investigators aim to contribute to the understanding of which disease mechanisms in the kidneys and heart that can be targeted in diabetic patients with kidney disease. This could hopefully provide better opportunities for preventing chronic kidney disease and kidney failure.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Finerenone (BAY 94-8862), Placebo
- Keywords
- Mineralocorticoid receptor antagonist (MRA), Type 2 diabetes, Chronic kidney disease, Diabetic complications, finerenone
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY 94-8862)Drug
Patients with an eGFR of 25-60 ml/min/1.73m2 will receive an initial dose of 10 mg finerenone/placebo once daily and those with an eGFR of at least 60 ml/ in/1.73m2 will receive an initial dose of 20 mg finerenone/placebo once daily. From 4 weeks the target dose is 20 mg finerenone/placebo once daily. An increase in dose from 10 to 20 mg once daily will be encouraged after 4 weeks provided the plasma potassium level is 4.8 mmol/L or less and the eGFR stable. If eGFR is reduced with >30 % compared to the previous measurement, we will not increase the dose of finerenone/placebo. Plasma potassium and eGFR will be measured 4 weeks after any initiation, re-start or increase in dose. A decrease in dose from 20 to 10 mg is allowed at any time after initiation of finerenone or placebo. Patients in the placebo group will undergo sham adjustment of the dose. Finerenone or placebo will be withheld if potassium concentrations exceed 5.5 mmol/L and restarted if potassium levels fall to 5.0 mmol/L
PlaceboDrug
Placebo tablets matching BAY94-8862 are administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Finerenone (active) | Experimental | Not described Receives: Drug: Finerenone (BAY 94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass measured by non-contrast cardiac MRI of the heart
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in albuminuria measured by a urinary albumin-to-creatinine ratio (UACR) in morning spot urine samples (first morning voids).
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Secondary outcomes (16)
Change in the rate of myocardial fibrosis (extracellular cardiac volume - ECV %) measured by MRI of the heart using gadolinium-containing contrast.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in the rate of myocardial fibrosis measured by non-contrast T1-mapping using MRI of the heart.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in left ventricular ejection fraction (EF), left ventricular and atrial volumes measured by non-contrast MRI of the heart.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in thoracic aortic wall volume (TWV) measured by MRI of the heart.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in the rate of pulse wave velocity in the aorta measured by non-contrast MRI of the heart.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in arterial stiffness assessed as cf-PWV.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in 24-hour blood pressure.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in inflammatory and fibrotic biomarkers related to CVD measured in blood and urine.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in measured glomerular filtration rate (mGFR) assessed by injection of a tracer.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in eGFR slope including all available outpatient eGFR measured a) from before treatment to last day of treatment b) from 4 weeks after treatment initiation to last day after treatment.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in UACR by repeated measures analysis including all available outpatient UACR measurements from before treatment to the last day after treatment.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in markers of the RAAS measured in blood and urine.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in inflammatory and fibrotic biomarkers related to CKD (e.g. markers of renal tubule damage) measured in blood and urine.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in kidney microstructure and fibrosis assessed as changes in T1-mapping and changes in the rate of ADC-values of diffusion-weighted MRI of the kidneys using non-contrast MRI.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in renal oxygenation assessed by BOLD MRI and change in renal perfusion with a pseudo continuous arterial spin labeling (pCASL), both non-contrast MR techniques
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Change in kidney size measured by a Dixon water/fat sequence MRI, a non-contrast MRI technique.
Measured: From the baseline visit at week 0 to the end of treatment at week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start23 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026539
- Sponsor's protocol ID
- 20235044465800
- Other IDs
- 2023-504446-58-00, 2023
- Acronym
- FineCaRe
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during the described study will not be publicly available due to privacy and ethical restrictions. Interested parties can request access to deidentified data or anonymised study reports by submitting a request to the primary investigator, provided that the necessary data protection agency and ethical committee approvals are given, in compliance with relevant legislation.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes - A Randomized Trial
- ClinicalTrials.gov ID
- NCT07026539
- Acronym / sponsor ID
- FineCaRe / 20235044465800
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, Cardiovascular Diseases
- Keywords
- Mineralocorticoid receptor antagonist (MRA), Type 2 diabetes, Chronic kidney disease, Diabetic complications, finerenone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 18 Jun 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.
The global prevalence of diabetes is increasing substantially. Around 40 % of patients with type 2 diabetes develop chronic kidney disease. Diabetic kidney disease is the leading cause of kidney failure, it is closely linked to cardiovascular disease and heart failure and is associated with a threefold increase in all-cause mortality and a 16-year loss in life expectancy.
In large clinical trials, the novel drug finerenone has shown to lower the risk of chronic kidney disease progression and improve the cardiovascular outcome for patients with type 2 diabetes and chronic kidney disease. However these trials did not not reflect current standard-of-care for patients with type 2 diabetes and chronic kidney disease, as only a minority (6.7 %) received an SGLT2-I - a treatment that has been considered standard-of-care for these patients since 2022.
The FineCaRe study aims to investigate the effect of treatment with finerenone in combination with an SGLT2-I on albuminuria and left ventricular mass in patients with type 2 diabetes and chronic kidney disease.
The investigators will perform a 26-week investigator-initiated, single-center, placebo-controlled, double-blinded randomized clinical trial. After screening and inclusion, participants will be randomized 1:1 to either finerenone or placebo treatment. Outcomes will be assessed at baseline, during and after 26 weeks of treatment.
The primary goal of the FineCaRe study is to acquire new knowledge that may help in preventing kidney failure in diabetic patients. With this project the investigators aim to contribute to the understanding of which disease mechanisms in the kidneys and heart that can be targeted in diabetic patients with kidney disease. This could hopefully provide better opportunities for preventing chronic kidney disease and kidney failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Finerenone (active) | Experimental | Drug: Finerenone (BAY 94-8862) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age above 18 years.
- Diagnosis of type 2 diabetes according to the World Health Organization definition.
- Current treatment with a SGLT2-I1 at maximally tolerated dose.
- Current treatment with an ACE inhibitor or an ARB1 at maximally tolerated dose.
- Plasma potassium level of 4.8 mmol/L or less at the time of screening.
Key exclusion criteria (17 listed)
- Inability to give informed consent.
- Severe renal disease with eGFR <25 ml/min/1.73m2.
- Severe hepatic disease (plasma ALAT above 3 x upper limit of normal).
- Active cancer diagnosis other than basal cell carcinoma.
- Treatment with systemic steroids at time of randomization.
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)Patients with an eGFR of 25-60 ml/min/1.73m2 will receive an initial dose of 10 mg finerenone/placebo once daily and those with an eGFR of at least 60 ml/ in/1.73m2 will receive an initial dose of 20 mg finerenone/placebo once daily. From 4 weeks the target dose is 20 mg finerenone/placebo once daily. An increase in dose from 10 to 20 mg once daily will be encouraged after 4 weeks provided the plasma potassium level is 4.8 mmol/L or less and the eGFR stable. If eGFR is reduced with >30 % compared to the previous measurement, we will not increase the dose of finerenone/placebo. Plasma potassium and eGFR will be measured 4 weeks after any initiation, re-start or increase in dose. A decrease in dose from 20 to 10 mg is allowed at any time after initiation of finerenone or placebo. Patients in the placebo group will undergo sham adjustment of the dose. Finerenone or placebo will be withheld if potassium concentrations exceed 5.5 mmol/L and restarted if potassium levels fall to 5.0 mmol/L | Drug | Finerenone (active) |
| PlaceboPlacebo tablets matching BAY94-8862 are administered orally. | Drug | Placebo |
Primary outcome
Change in left ventricular mass measured by non-contrast cardiac MRI of the heart
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in albuminuria measured by a urinary albumin-to-creatinine ratio (UACR) in morning spot urine samples (first morning voids).
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
16 secondary outcomes
Change in the rate of myocardial fibrosis (extracellular cardiac volume - ECV %) measured by MRI of the heart using gadolinium-containing contrast.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in the rate of myocardial fibrosis measured by non-contrast T1-mapping using MRI of the heart.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in left ventricular ejection fraction (EF), left ventricular and atrial volumes measured by non-contrast MRI of the heart.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in thoracic aortic wall volume (TWV) measured by MRI of the heart.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in the rate of pulse wave velocity in the aorta measured by non-contrast MRI of the heart.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in arterial stiffness assessed as cf-PWV.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in 24-hour blood pressure.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in inflammatory and fibrotic biomarkers related to CVD measured in blood and urine.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in measured glomerular filtration rate (mGFR) assessed by injection of a tracer.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in eGFR slope including all available outpatient eGFR measured a) from before treatment to last day of treatment b) from 4 weeks after treatment initiation to last day after treatment.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in UACR by repeated measures analysis including all available outpatient UACR measurements from before treatment to the last day after treatment.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in markers of the RAAS measured in blood and urine.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in inflammatory and fibrotic biomarkers related to CKD (e.g. markers of renal tubule damage) measured in blood and urine.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in kidney microstructure and fibrosis assessed as changes in T1-mapping and changes in the rate of ADC-values of diffusion-weighted MRI of the kidneys using non-contrast MRI.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in renal oxygenation assessed by BOLD MRI and change in renal perfusion with a pseudo continuous arterial spin labeling (pCASL), both non-contrast MR techniques
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
Change in kidney size measured by a Dixon water/fat sequence MRI, a non-contrast MRI technique.
Time frame: From the baseline visit at week 0 to the end of treatment at week 26.
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 24 Jun 2025.
- Individual participant dataSharing planned: Yes. The datasets generated during the described study will not be publicly available due to privacy and ethical restrictions. Interested parties can request access to deidentified data or anonymised study reports by submitting a request to the primary investigator, provided that the necessary data protection agency and ethical committee approvals are given, in compliance with relevant legislation.
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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.
Per L Poulsen, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone (BAY 94-8862) in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease Due to Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 17 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 24 Jun 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lene Halkjær, MD (+4528928399, lene.halkjaer@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass measured by non-contrast cardiac MRI of the heart (time frame: From the baseline visit at week 0 to the end of treatment at week 26.). The study lists 2 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 24 Jun 2025.