Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT07667517
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Albuminuria
  • Chronic Kidney Diseases
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

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

Interventions

  • Finerenone (BAY 94-8862) — DRUG
    Oral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.
  • Placebo — DRUG
    Matching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR \>= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\<300 vs \>=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Finerenone film-coated tablets, orally once daily, on top of standard background therapy. Starting dose determined by screening eGFR: 10 mg if 30 \<= eGFR \< 60 mL/min/1.73 m\^2, or 20 mg if eGFR \>= 60 mL/min/1.73 m\^2. Dose up-titrated to 20 mg, maintained, interrupted, or down-titrated to 10 mg based on serum potassium and eGFR. Treatment duration 180 days.
  • Placebo Comparator: Placebo
    Matching placebo tablets identical in appearance to finerenone, orally once daily, on top of standard background therapy, following the same dosing and titration schedule. Treatment duration 180 days.

Primary Outcome Measure

Albuminuria regression rate [ Time Frame: 180 days ]

Central Contacts

Related Studies