Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

NCT07056595 | Recruiting DMC

• 1 other identifier: IEC-6/13052025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (1)

• Median change in albuminuria from baseline

  24-hour urinary albumin excretion

  6 months

Other Outcomes (1)

• Median change in eGFR from baseline

  6 months

Study Arms (3)

iRAS

EXPERIMENTAL

Drug: Finerenone

iSGLT2

EXPERIMENTAL

Drug: Finerenone

iRAS+iSGLT2

EXPERIMENTAL

Drug: Finerenone

Interventions

Finerenone DRUG

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

iRAS; iRAS+iSGLT2; iSGLT2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> 18 years) with the primary IgAN diagnosed by kidney biopsy;
• Blood pressure \< 140/90 mm Hg
• hour urinary albumin excretion \> 300 mg

You may not qualify if:

• 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

Sponsors & Collaborators

• Botkin Hospital: lead

Study Sites (1)

Botkin Hospital

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

finerenone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Evgeny Shytov, PhD

CONTACT

+7 499 490 03 03; shutov_e_v@mail.ru

Anastasiia Zykova, PhD

CONTACT

ansezy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

RU (1)