Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2026-05-21

Brief Summary

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: 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.

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Detailed Description

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Conditions

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IgA Nephropathy (IgAN)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

* Adults (\> 18 years) with the primary IgAN diagnosed by kidney biopsy;
* Treatment with stable doses of iRAS or/and iSGLT2 inhibitors for at least 3 months prior inclusion into the trial;
* Blood pressure \< 140/90 mm Hg
* 24-hour urinary albumin excretion \> 300 mg

Exclusion Criteria

* Kidney transplantation in medical history
* Chronic hepatic disease, including hepatitis, malignant tumor, active malignancy;
* Heart failure with ejection fraction \<40%;
* Acute myocardial infarction and/or stroke less then 3 months before including in trial;
* Presence ANCA in serum
* Ongoing immunosuppressive treatment
* eGFR \< 20 ml/min
* Pregnancy and breastfeeding
* Uncontrolled blood pressure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No