Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07056595

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Led by Botkin Hospital · Updated on 2025-07-09

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

: 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.

CONDITIONS

Official Title

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (> 18 years) with primary IgA nephropathy diagnosed by kidney biopsy
  • Treatment with stable doses of iRAS or/and iSGLT2 inhibitors for at least 3 months before joining
  • Blood pressure less than 140/90 mm Hg
  • 24-hour urinary albumin excretion greater than 300 mg
Not Eligible

You will not qualify if you...

  • History of kidney transplantation
  • Chronic liver disease including hepatitis or active malignancy
  • Heart failure with ejection fraction below 40%
  • Acute myocardial infarction or stroke within 3 months prior to the trial
  • Presence of ANCA in serum
  • Ongoing immunosuppressive treatment
  • Estimated glomerular filtration rate (eGFR) below 20 ml/min
  • Pregnancy or breastfeeding
  • Uncontrolled blood pressure

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Botkin Hospital

Moscow, Russia

Actively Recruiting

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Research Team

E

Evgeny Shytov, PhD

CONTACT

A

Anastasiia Zykova, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial | DecenTrialz