Skip to main content
OpenTrials
Completed

NCT Number: NCT06835322

Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

About this study

In patients with type 2 diabetes and advanced CKD, finerenone resulted in lower risks of CKD progression and cardiovascular events. Mineralocorticoid receptor over activation in the kidney leads to inflammation and fibrosis with subsequent progressive kidney disease. Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, had more potent anti-inflammatory and ant fibrotic effects than steroidal mineralocorticoid receptor antagonists. Finerenone has been shown to reduce the urinary albumin-to-creatinine ratio in patients with CKD treated with an RAS blocker, while having smaller effects on serum potassium levels than spironolactone.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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 9 months.

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 9 months.

Primary outcomes

  1. - Change in kidney function

    Time frame: 9 months

    By assessing change in eGFR

  2. - Change in proteinuria

    Time frame: 9 months

    By assessing change in protein to creatinine ratio

  3. Change in kidney function

    Time frame: 9 months

    By assessing change in serum creatinine

Secondary outcomes

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

    Time frame: 9 months

    By assessing serum K at baseline, then monthly

  2. - Need for hospitalization

    Time frame: 9 months

    By assessing the need for hospital admission

  3. - Serious adverse events

    Time frame: 9 months

    By reporting any serious adverse events during and after study for 2 weeks.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Finerenone on Proteinuria and GFR Progression in Patients With Non Diabetic Glomerulonephritis: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.