Actively Recruiting
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
Led by University of Aarhus · Updated on 2025-06-24
80
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18 years.
- Diagnosis of type 2 diabetes according to the World Health Organization definition.
- Current treatment with a SGLT2-I at maximally tolerated dose.
- Current treatment with an ACE inhibitor or an ARB at maximally tolerated dose.
- Plasma potassium level of 4.8 mmol/L or less at the time of screening.
- Chronic kidney disease defined as eGFR 65 ml/min/1.73 m2 and albuminuria (UACR between 30-5000 mg/g).
- Speak and understand Danish fluently.
You will not qualify if you...
- 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 compliance.
- Chronic or acute pancreatitis.
- Pregnancy or breastfeeding.
- Poorly controlled medical condition such as advanced heart failure, recent stroke or myocardial infarction, or other risks as judged by investigator.
- Allergy to finerenone or any excipients in the drug.
- Current systemic treatment with strong CYP3A4 inhibitors or inducers.
- Current treatment with other mineralocorticoid receptor antagonists.
- Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Addison's disease.
- Contraindications to MRI.
- Previous renal or heart transplantation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Aarhus
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
L
Lene Halkjær, MD
CONTACT
P
Per L Poulsen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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