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COMPLETED
NCT07819227
PHASE2

Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

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.

Official title: Optimization of Albuminuria Lowering Therapies to Individual Patients With CKD Using FINErenone and SEmaglutide

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2025-02-11

Completion Date

2026-08-31

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

Finerenone (BAY 94-8862)

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.

DRUG

Semaglutide 14 MG [Rybelsus]

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.

DRUG

Finerenone and Semaglutide

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.

Locations (6)

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