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NCT Number: NCT07026539

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Due to Type 2 Diabetes Mellitus Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

Placebo tablets matching BAY94-8862 are administered orally.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change in 24-hour blood pressure.

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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Other outcomes

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

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

  2. Change in retinal oxygenation measured by oximetry.

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

  3. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lene Halkjær, MD

CONTACT

[email protected]

+4528928399

Per L Poulsen, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: FineCaRe

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 18, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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