Finerenone for adults with IgA nephropathy
Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
NA · Botkin Hospital · NCT07056595
This trial will try finerenone, a nonsteroidal mineralocorticoid receptor blocker, to lower excess urine albumin in adults with biopsy-proven IgA nephropathy who are on stable kidney-protective medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Botkin Hospital (other) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07056595 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional trial testing finerenone in adults with biopsy-confirmed IgA nephropathy and significant albuminuria. Eligible participants must have 24-hour urine albumin excretion over 300 mg, controlled blood pressure, and stable treatment with RAAS blockers and/or SGLT2 inhibitors for at least three months. Participants will receive finerenone and be monitored for changes in albuminuria, kidney function (eGFR), serum potassium, and adverse events. The trial is conducted at a single center (Botkin Hospital, Moscow) with predefined exclusion criteria including low eGFR, prior transplant, active malignancy, ongoing immunosuppression, and recent major cardiovascular events.
Who should consider this trial
Good fit: Adults over 18 with biopsy-proven IgA nephropathy, 24-hour urine albumin >300 mg, controlled blood pressure, and on stable RAAS and/or SGLT2 inhibitor therapy for at least three months are ideal candidates.
Not a fit: People with prior kidney transplant, eGFR <20 ml/min, active or recent malignancy, ongoing immunosuppressive treatment, positive ANCA, uncontrolled blood pressure, recent myocardial infarction or stroke, pregnancy, or breastfeeding are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If effective, finerenone could reduce albuminuria and help slow kidney damage in people with IgA nephropathy, possibly delaying need for dialysis or transplant.
How similar studies have performed: Large trials in CKD with type 2 diabetes (FIGARO‑DKD and FIDELIO, pooled as FIDELITY) showed finerenone reduces albuminuria and provides cardiorenal benefit, but its effects specifically in IgA nephropathy are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- Botkin Hospital — Moscow, Russia (RECRUITING)
Study contacts
- Study coordinator: Evgeny Shytov, PhD
- Email: shutov_e_v@mail.ru
- Phone: +7 499 490 03 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IgA Nephropathy