Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide

Sponsor
University Medical Center Groningen
Study ID
NCT07819227
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone (BAY 94-8862) — DRUG
    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.
  • Semaglutide 14 MG [Rybelsus] — DRUG
    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.
  • Finerenone and Semaglutide — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 14, 2026
Start date
Feb 11, 2025
Status verified
Sep 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment order 1
    6 weeks finerenone monotherapy → 6-week wash-out → 12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out.
  • Experimental: Treatment order 2
    12 weeks semaglutide monotherapy → 6 weeks finerenone + semaglutide combination therapy → 6-week wash-out → 6 weeks finerenone monotherapy → 6-week wash-out.

Primary Outcome Measure

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) ]

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