RecruitingNot ApplicableNCT07056595

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial


Sponsor

Botkin Hospital

Enrollment

30 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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
  • -hour urinary albumin excretion > 300 mg

Exclusion Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFinerenone

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


Locations(1)

Botkin Hospital

Moscow, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07056595


Related Trials