Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Botkin Hospital
RECRUITING
Moscow
Contact Information
Primary
Evgeny Shytov, PhD
shutov_e_v@mail.ru
+7 499 490 03 03
Backup
Anastasiia Zykova, PhD
ansezy@gmail.com
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2026-05-21
Participants
Target number of participants: 30
Treatments
Experimental: iRAS
Experimental: iSGLT2
Experimental: iRAS+iSGLT2
Sponsors
Leads: Botkin Hospital

This content was sourced from clinicaltrials.gov