NCT07026539RecruitingPhase 4
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes - A Randomized Trial
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 23 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07026539
- EU CT number
- 2023-504446-58-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From 23 Oct 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
- 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.).
- Previous renal or heart transplantation.
Other illness
- Severe hepatic disease (plasma ALAT above 3 x upper limit of normal).
- Active cancer diagnosis other than basal cell carcinoma.
- 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.
- 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.
- Addison's disease.
Lab values
- Severe renal disease with eGFR \<25 ml/min/1.73m2.
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption.
Other
- Inability to give informed consent.
- Chronic or acute pancreatitis.
- Pregnancy or breastfeeding (see pregnancy below).
- Contraindications to MRI.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.