NCT07056595 Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
| NCT ID | NCT07056595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Botkin Hospital |
| Condition | IgA Nephropathy (IgAN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-05-21 with a primary completion date of 2026-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07056595 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IgA Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07056595 currently recruiting?
Yes, NCT07056595 is actively recruiting participants. Contact the research team at shutov_e_v@mail.ru for enrollment information.
Where is the NCT07056595 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07056595 clinical trial?
NCT07056595 is sponsored by Botkin Hospital. The trial plans to enroll 30 participants.