Condition: Type 2 Diabetes Mellitus (T2DM) · Chronic Kidney Disease Due to Type 2 Diabetes Mellitus · Cardiovascular Diseases · Sponsor: University of Aarhus
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 ki…
This description comes directly from the study's public registry record.
Lene Halkjær, MD · +4528928399 · lene.halkjaer@clin.au.dk
Per L Poulsen, Professor · perpouls@rm.dk
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| Steno Diabetes Center Aarhus | Aarhus N, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07026539