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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Finerenone plus SGLT2 inhibitor for kidney and heart protection in type 2 diabetes

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

Run by University of Aarhus · NCT07026539 · Data updated 2026-11-12

This will test whether adding finerenone to SGLT2 inhibitor therapy reduces albuminuria and left ventricular damage in adults with type 2 diabetes and chronic kidney disease.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations1 site (Aarhus N)
StatusRecruiting
StartedOctober 23, 2024
Main results expectedDecember 31, 2026
Study endsApril 30, 2028
Registry record updatedJune 24, 2025
Trial IDNCT07026539 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with type 2 diabetes and CKD (eGFR ≥25 ml/min/1.73 m2 and UACR 30–5000 mg/g) who are on maximally tolerated SGLT2 inhibitor and ACE inhibitor or ARB therapy, have plasma potassium ≤4.8 mmol/L, and can consent in Danish.

Probably not a fit

Patients with severe renal impairment (eGFR <25 ml/min/1.73 m2), significant hepatic disease, active cancer, recent bariatric or malabsorptive surgery, current systemic steroid treatment, recent substance abuse, inability to consent, or those not on SGLT2 inhibitor plus ACEi/ARB are unlikely to qualify or benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FineCaRe is a randomized, placebo-controlled Phase 4 trial comparing finerenone to placebo in adults with type 2 diabetes and chronic kidney disease who are already treated with an SGLT2 inhibitor and an ACE inhibitor or ARB. Eligible participants have eGFR ≥25 ml/min/1.73 m2 and albuminuria (UACR 30–5000 mg/g) and must meet potassium and other safety criteria. The trial's primary outcomes focus on changes in albuminuria and left ventricular parameters to capture renal and cardiac target-organ effects. The study is led by Aarhus University and conducted at Steno Diabetes Center Aarhus in Denmark.

Why it matters

Potential benefit: If successful, adding finerenone could further slow kidney disease progression and reduce cardiac damage on top of current SGLT2 inhibitor therapy.

How similar studies have gone: Large trials of finerenone (FIDELIO‑DKD and FIGARO‑DKD) demonstrated kidney and cardiovascular benefits, but those trials included few patients on SGLT2 inhibitors so robust data on the combination remain limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Steno Diabetes Center Aarhus
    Aarhus N, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68Cardiovascular Diseases 365University of Aarhus 153
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.