Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Sponsor
Botkin Hospital
Study ID
NCT07056595
Status
Recruiting
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Conditions

  • IgA Nephropathy (IgAN)

Eligibility Criteria

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

Interventions

  • Finerenone — DRUG
    Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist. Planned dose - 10 mg/day

Study Details

: IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.

Key Dates

Start date
May 21, 2025
Status verified
Jun 2025
Primary completion
May 21, 2026
Completion
May 21, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iRAS
  • Experimental: iSGLT2
  • Experimental: iRAS+iSGLT2

Primary Outcome Measure

Median change in albuminuria from baseline [ Time Frame: 6 months ]

Central Contacts

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