Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

May 26, 2026 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. GN patients on maximum tolerated doses of an ACEi or ARBs together with their immunosuppression protocol (if needed) for at least 4 weeks.
  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:

  1. Patients with diabetes mellitus (type 1 or 2).
  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 9 months.
Drug: 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 9 months.
Placebo Comparator: placebo
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.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Change in kidney function
Time Frame: 9 months
By assessing change in eGFR
9 months
- Change in proteinuria
Time Frame: 9 months
By assessing change in protein to creatinine ratio
9 months
Change in kidney function
Time Frame: 9 months
By assessing change in serum creatinine
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Occurrence of hyperkalemia (potassium level >5 mEq/L)
Time Frame: 9 months
By assessing serum K at baseline, then monthly
9 months
- Need for hospitalization
Time Frame: 9 months
By assessing the need for hospital admission
9 months
- Serious adverse events
Time Frame: 9 months
By reporting any serious adverse events during and after study for 2 weeks.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Mamdouh Elsayed, MD, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Finerenone and GN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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