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.
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.
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.
Parallel
Finerenone (BAY 94-8862)
DrugPatients 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
DrugPlacebo tablets matching BAY94-8862 are administered orally.
Change in left ventricular mass measured by non-contrast cardiac MRI of the heart
Change in albuminuria measured by a urinary albumin-to-creatinine ratio (UACR) in morning spot urine samples (first morning voids).
Change in the rate of myocardial fibrosis (extracellular cardiac volume - ECV %) measured by MRI of the heart using gadolinium-containing contrast.
Change in the rate of myocardial fibrosis measured by non-contrast T1-mapping using MRI of the heart.
Change in left ventricular ejection fraction (EF), left ventricular and atrial volumes measured by non-contrast MRI of the heart.
Change in thoracic aortic wall volume (TWV) measured by MRI of the heart.
Change in retinal thickness assessed with Optical Coherence Tomography (OCT).
Change in retinal oxygenation measured by oximetry.
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
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
