NCT07026539 Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.
| NCT ID | NCT07026539 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Aarhus |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2024-10-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07026539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07026539 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07026539 currently recruiting?
Yes, NCT07026539 is actively recruiting participants. Contact the research team at lene.halkjaer@clin.au.dk for enrollment information.
Where is the NCT07026539 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT07026539 clinical trial?
NCT07026539 is sponsored by University of Aarhus. The trial plans to enroll 80 participants.
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