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

NCT07026539 | Recruiting Phase 4

• 2 other identifiers: 202350444658002023-504446-58-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Mineralocorticoid receptor antagonist (MRA); Type 2 diabetes; Chronic kidney disease; Diabetic complications; finerenone

Outcome Measures

Primary Outcomes (2)

• Change in left ventricular mass measured by non-contrast cardiac MRI of the heart

  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).

  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.

  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.

  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.

  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.

  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.

  From the baseline visit at week 0 to the end of treatment at week 26.

Other Outcomes (3)

• Change in retinal thickness assessed with Optical Coherence Tomography (OCT).

  From the baseline visit at week 0 to the end of treatment at week 26.

• Change in retinal oxygenation measured by oximetry.

  From the baseline visit at week 0 to the end of treatment at week 26.

• Change in the transcriptomic, proteomic, and/or metabolomic profile in plasma and urine. Furthermore, to test if possible changes can be related to pathways involved in and/or serve as biomarkers of the progression of cardiovascular and/or kidney disease

  From the baseline visit at week 0 to the end of treatment at week 26.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Finerenone (active)

EXPERIMENTAL

Drug: Finerenone (BAY 94-8862)

Interventions

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

Finerenone (active)

Placebo DRUG

Placebo tablets matching BAY94-8862 are administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Renal Insufficiency, Chronic; Diabetes Complications

Interventions

finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lene Halkjær, MD

CONTACT

+4528928399; lene.halkjaer@clin.au.dk

Per L Poulsen, Professor

CONTACT

perpouls@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: October 23, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)