💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Finerenone (BAY 94-8862)
- Placebo
Steno Diabetes Center Aarhus
Aarhus N, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky