IgA Nephropathy (IgAN)NCT07056595
Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
A study testing Finerenone in people with IgA Nephropathy (IgAN), run by Botkin Hospital at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- Finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 21 May 2025to 21 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- eGFR < 20 ml/min
- Pregnancy and breastfeeding
- Uncontrolled blood pressure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anastasiia Zykova, PhD contact
Russia1 site, 1 recruiting
- Recruiting
Botkin Hospital
Moscow
Anastasiia Zykova, 89151345432, ansezy@gmail.com
About this study
: 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
- IgA Nephropathy (IgAN)
- Being tested
- Finerenone
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist. Planned dose - 10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| iRAS | Experimental | Not described Receives: Drug: Finerenone |
| iSGLT2 | Experimental | Not described Receives: Drug: Finerenone |
| iRAS+iSGLT2 | Experimental | Not described Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median change in albuminuria from baseline
24-hour urinary albumin excretion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start21 May 2025
- Primary completion21 May 2026 (estimated)
- Study completion21 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botkin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny Shutov, Botkin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056595
- Sponsor's protocol ID
- IEC-6/13052025
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
- ClinicalTrials.gov ID
- NCT07056595
- Acronym / sponsor ID
- IEC-6/13052025
- Conditions
- IgA Nephropathy (IgAN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Botkin HospitalUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 21 May 2026 (estimated)
- Study completion
- 21 May 2026 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iRAS | Experimental | Drug: Finerenone |
| iSGLT2 | Experimental | Drug: Finerenone |
| iRAS+iSGLT2 | Experimental | Drug: Finerenone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneFinerenone is a new nonsteroidal mineralocorticoid receptor antagonist. Planned dose - 10 mg/day | Drug | iRAS, iRAS+iSGLT2, iSGLT2 |
Primary outcome
Median change in albuminuria from baseline
Time frame: 6 months
24-hour urinary albumin excretion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anastasiia Zykova, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finerenone in people with IgA Nephropathy (IgAN), run by Botkin Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Shytov, PhD (+7 499 490 03 03 ext. 5844, shutov_e_v@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median change in albuminuria from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.