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

University of Aarhus

Status and phase

Enrolling

Phase 4

Conditions

Chronic Kidney Disease Due to Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM)

Cardiovascular Diseases

Treatments

Drug: Placebo

Drug: Finerenone (BAY 94-8862)

Study type

Interventional

Funder types

Other

Identifiers

NCT07026539

2023-504446-58-00 (EU Trial (CTIS) Number)

20235044465800

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.