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

Launched by UNIVERSITY OF AARHUS · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called finerenone to see how well it works together with another common diabetes treatment (called SGLT2 inhibitors) to protect the kidneys and heart in people with type 2 diabetes who also have kidney problems. Since many people with type 2 diabetes develop kidney disease, which can lead to serious heart issues and kidney failure, this study hopes to find better ways to prevent these complications and improve health and life expectancy.

If you have type 2 diabetes, are at least 18 years old, and are already taking an SGLT2 inhibitor and other standard treatments for your condition, you might be eligible to join. The study lasts about 26 weeks, during which you would receive either finerenone or a placebo (a dummy pill) without knowing which one, and your kidney and heart health will be carefully monitored through tests. The trial is currently recruiting participants who meet the criteria and can speak Danish. This research aims to discover new ways to protect your kidneys and heart, potentially helping many people with diabetes live healthier lives.

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Eligibility criteria

• 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.