Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis
NCT ID: NCT06835322
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-02-20
2025-09-10
Brief Summary
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Detailed Description
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Glomerulonephritis (GN) is an inflammation affecting kidney glomeruli, and is considered an important cause of CKD. Reducing proteinuria is one of the main therapeutic targets in patients with GN.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
SINGLE
Study Groups
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interventional
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.
Finerenone
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.
placebo
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
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.
Interventions
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Finerenone
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
2. urinary protein excretion \>500 mg/g.
3. Adult patients with age above 18 years.
4. eGFR ≥ 25 mL/ min/1.73 m2.
5. baseline serum potassium level \<5 mEq/L.
Exclusion Criteria
2. Other non-glomerular kidney diseases.
3. Heart failure.
4. Breast feeding or pregnancy.
5. Patients who received medications to treat hyperkalemia 4 weeks before study.
6. Uncontrolled hypertension (BP \> 160/100).
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD
Associate professor
Principal Investigators
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Mohamed Mamdouh Elsayed, MD
Role: PRINCIPAL_INVESTIGATOR
Associate professor
Locations
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Faculty of Medicine, Aexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Finerenone and GN
Identifier Type: -
Identifier Source: org_study_id
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