Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

NCT06835322 | Recruiting Phase 2

• 1 other identifier: Finerenone and GN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of finerenone on proteinuria and GFR progression in patients with non-diabetic glomerulonephritis.

Conditions

Glomerulonephritis

Keywords

finerenone; proteinuria; GFR progression; glomerulonephritis

Outcome Measures

Primary Outcomes (3)

• - Change in kidney function

  By assessing change in eGFR

  6 months

• - Change in proteinuria

  By assessing change in protein to creatinine ratio

  6 months

• Change in kidney function

  By assessing change in serum creatinine

  6 months

Secondary Outcomes (3)

• - Occurrence of hyperkalemia (potassium level >5 mEq/L)

  6 months

• - Need for hospitalization

  6 months

• - Serious adverse events

  6 months

Study Arms (2)

interventional

EXPERIMENTAL

50 patients with biopsy proven glomerulonephritis who will receive 10 - 20 mg finerenone once daily orally in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

Drug: Finerenone

placebo

PLACEBO COMPARATOR

50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

Drug: Placebo

Interventions

Finerenone DRUG

50 patients with biopsy proven glomerulonephritis who will receive 10 - 20 mg finerenone once daily orally in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

interventional

Placebo DRUG

50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

placebo

Eligibility Criteria

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

You may qualify if:

• GN patients on maximum tolerated doses of an ACEi or ARBs together with their immunosuppression protocol (if needed) for at least 4 weeks.
• urinary protein excretion \>500 mg/g.
• Adult patients with age above 18 years.
• eGFR ≥ 25 mL/ min/1.73 m2.
• baseline serum potassium level \<5 mEq/L.

You may not qualify if:

• Patients with diabetes mellitus (type 1 or 2).
• Other non-glomerular kidney diseases.
• Heart failure.
• Breast feeding or pregnancy.
• Patients who received medications to treat hyperkalemia 4 weeks before study.
• Uncontrolled hypertension (BP \> 160/100).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

RECRUITING

Related Publications (7)

• Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

  PMID: 33264825 BACKGROUND

• Ruilope LM, Pitt B, Anker SD, Rossing P, Kovesdy CP, Pecoits-Filho R, Pergola P, Joseph A, Lage A, Mentenich N, Scheerer MF, Bakris GL. Kidney outcomes with finerenone: an analysis from the FIGARO-DKD study. Nephrol Dial Transplant. 2023 Feb 13;38(2):372-383. doi: 10.1093/ndt/gfac157.

  PMID: 35451488 BACKGROUND

• Barrera-Chimal J, Girerd S, Jaisser F. Mineralocorticoid receptor antagonists and kidney diseases: pathophysiological basis. Kidney Int. 2019 Aug;96(2):302-319. doi: 10.1016/j.kint.2019.02.030. Epub 2019 Mar 13.

  PMID: 31133455 BACKGROUND

• Grune J, Beyhoff N, Smeir E, Chudek R, Blumrich A, Ban Z, Brix S, Betz IR, Schupp M, Foryst-Ludwig A, Klopfleisch R, Stawowy P, Houtman R, Kolkhof P, Kintscher U. Selective Mineralocorticoid Receptor Cofactor Modulation as Molecular Basis for Finerenone's Antifibrotic Activity. Hypertension. 2018 Apr;71(4):599-608. doi: 10.1161/HYPERTENSIONAHA.117.10360. Epub 2018 Feb 5.

  PMID: 29437893 BACKGROUND

• Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

  PMID: 26325557 BACKGROUND

• Hou JH, Zhu HX, Zhou ML, Le WB, Zeng CH, Liang SS, Xu F, Liang DD, Shao SJ, Liu Y, Liu ZH. Changes in the Spectrum of Kidney Diseases: An Analysis of 40,759 Biopsy-Proven Cases from 2003 to 2014 in China. Kidney Dis (Basel). 2018 Feb;4(1):10-19. doi: 10.1159/000484717. Epub 2017 Dec 8.

  PMID: 29594138 BACKGROUND

• AlYousef A, AlSahow A, AlHelal B, Alqallaf A, Abdallah E, Abdellatif M, Nawar H, Elmahalawy R. Glomerulonephritis Histopathological Pattern Change. BMC Nephrol. 2020 May 18;21(1):186. doi: 10.1186/s12882-020-01836-3.

  PMID: 32423387 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis; Proteinuria

Interventions

finerenone

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Mamdouh Elsayed, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Mamdouh Elsayed, MD

CONTACT

00201068055103; dr_mohamedmamdouh87@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This research is a prospective randomized multicentric clinical trial in which 100 patients with biopsy proven glomerulonephritis (exception is nephrotic patients with positive anti-PLA2R indicative of primary membranous) will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 50 patients with biopsy proven glomerulonephritis who will receive 10 - 20 mg finerenone once daily orally in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months. * Group B: 50 patients with biopsy proven glomerulonephritis who will receive placebo once daily in addition to their regular treatment protocol (RAAS blockers ± immunosuppression) for 6 months.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: February 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: September 10, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)