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NCT Number: NCT07056595

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

: 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Finerenone

Drug

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

Primary outcomes

  1. Median change in albuminuria from baseline

    Time frame: 6 months

    24-hour urinary albumin excretion

Other outcomes

  1. Median change in eGFR from baseline

    Time frame: 6 months

    calculated based on creatinine level

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasiia Zykova, PhD

CONTACT

[email protected]

Evgeny Shytov, PhD

CONTACT

[email protected]

+7 499 490 03 03 ext. 5844

Sponsors and collaborators

Lead sponsor

Botkin Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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