The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria. Approximately 36 participants will receive both treatments in a randomized crossover design, with the aim of identifying which treatment provides the greatest individual reduction in albuminuria. The primary objective is to determine whether a reduction of at least 30% in albuminuria can be achieved. The study will also assess the effect of combining both treatments and the feasibility of remotely monitoring treatment response through home measurements and urine collections. The total study duration is approximately 40 weeks.
The FINESSE-CKD trial investigates whether treatment for chronic kidney disease (CKD) can be personalized based on an individual patient's response to finerenone and semaglutide. Although both treatments have been shown to reduce albuminuria and improve kidney and cardiovascular outcomes in relevant patient populations, treatment response can vary considerably between individuals. The study therefore aims to identify whether selecting the treatment that provides the greatest reduction in albuminuria for each individual patient can achieve a clinically relevant reduction of at least 30% in urinary albumin-to-creatinine ratio (UACR). This is a randomized, open-label, crossover, multicenter, decentralized clinical trial. Participants will receive finerenone and semaglutide according to the study treatment schedule, allowing the response to each treatment to be assessed within the same individual. The study will also evaluate whether combined treatment with finerenone and semaglutide provides additional albuminuria lowering compared with the individually selected treatment. A decentralized approach will be used to reduce the need for hospital visits and assess the feasibility of monitoring treatment response remotely. Participants will perform selected measurements and urine collections at home, including monitoring of body weight and blood pressure. The primary outcome is the proportion of participants achieving a ≥30% reduction in UACR. Secondary outcomes include the percentage change in UACR from baseline and the feasibility of remote urine collection. The study is expected to provide insight into whether an individualized treatment strategy can improve the effectiveness of albuminuria-lowering therapy while reducing unnecessary treatment and patient burden.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
The dose of oral finerenone is 20 mg/day (up-titrate from 10 mg/day in patients with an eGFR \<60 mL/min/1.73m2 (up-titrate from 10 mg/day in patients with an eGFR \<60 mL/min/1.73m2). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. oral film-coated tablet.
14 mg once daily (registered maximum dose, up-titrate from 3 mg and 7 mg once daily). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. Oral tablet.
After 4 weeks of maximum tolerated semaglutide, participants will receive combined oral finerenone and semaglutide for 6 weeks. The procedures during the 6 weeks treatment period are the same as those during the finerenone only treatment periods. Because the combination treatment period immediately follows the semaglutide monotherapy treatment period, no additional titration of semaglutide is necessary. During the combination treatment period, the dose of finerenone will be uptitrated after 2 weeks in patients with eGFR ≥60 mL/min/1.73m2 and serum potassium ≤5.0 mmol/L.
Steno Diabetes Center
Copenhagen, Denmark
University of Calabria
Cosenza, Italy
University of Campania
Naples, Italy
Ziekenhuisgroep Twente
Almelo, Netherlands
Hospital Vall d'Hebron
Barcelona, Spain
Hospital University Clinica Incliva
Valencia, Spain
Proportion of patients with ≥30% reduction in urinary albumin:creatinine ratio (UACR) from baseline during monotherapy with finerenone or semaglutide or combined treatment with finerenone-semaglutide.
Time frame: From baseline to the end of study (Week 37)
Percentage change in UACR
Time frame: From baseline to end of study (week 37)
Number of missed urine collection in the remote (@home) setting
Time frame: From baseline to end of study (Week 37)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.