Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.

NCT ID: NCT07026539

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2028-04-30

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Disease Due to Type 2 Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets matching BAY94-8862 are administered orally.

Finerenone (active)

Group Type: EXPERIMENTAL

Finerenone (BAY 94-8862)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Placebo

Placebo tablets matching BAY94-8862 are administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Steno Diabetes Center Aarhus

Aarhus N, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Lene Halkjær, MD

Role: CONTACT

lene.halkjaer@clin.au.dk

+4528928399

Per L Poulsen, Professor

Role: CONTACT

perpouls@rm.dk

Facility Contacts

Lene Halkjær, MD

Role: primary

lene.halkjaer@clin.au.dk

+4528928399

Anna Dons-Jensen, MD

Role: backup

adj@clin.au.dk

+4525723131

Other Identifiers

2023-504446-58-00

Identifier Type: CTIS

Identifier Source: secondary_id

20235044465800

Identifier Type: -

Identifier Source: org_study_id