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RecruitingNCT07056595Updated Jul 9, 2025

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

An interventional study of Finerenone in IgA Nephropathy (IgAN), sponsored by Botkin Hospital. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Botkin Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

: 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.

02

Conditions studied

  • IgA Nephropathy (IgAN)
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 30 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Botkin Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults (> 18 years) with the primary IgAN diagnosed by kidney ;
  • 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

Exclusion Criteria:

  • Kidney transplantation in medical history
  • Chronic hepatic disease, including hepatitis, malignant tumor, active ;
  • Heart failure with \<40%;
  • Acute myocardial infarction and/or stroke less then 3 months before including in trial;
  • Presence ANCA in serum
  • Ongoing treatment
  • \< 20 ml/min
  • Pregnancy and breastfeeding
  • Uncontrolled blood pressure
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    iRAS

    Drug: Finerenone

  • Experimental
    iSGLT2

    Drug: Finerenone

  • Experimental
    iRAS+iSGLT2

    Drug: Finerenone

Interventions

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

06

What researchers measure

Primary outcomes

  1. Median change in albuminuria from baseline

    24-hour urinary albumin excretion

    Time frame: 6 months

Other outcomes

  1. Median change in eGFR from baseline

    calculated based on creatinine level

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07056595
Lead sponsor
Botkin Hospital
Responsible party
Evgeny Shutov (Senior Researcher, Botkin Hospital) — Principal investigator
First posted
Jul 9, 2025
Start date
May 21, 2025
Primary completion
May 21, 2026 (estimated)
Completion
May 21, 2026 (estimated)
Last update
Jul 9, 2025

Study contacts

Evgeny Shytov, PhD
Contact
shutov_e_v@mail.ru
+7 499 490 03 03 ext. 5844
Anastasiia Zykova, PhD
Contact
ansezy@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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