SGLT2 inhibitors added to standard care in adult primary nephrotic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label study compares three groups of adults with biopsy-confirmed primary nephrotic syndrome: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone. Participants must have an eGFR of at least 25 mL/min/1.73 m² and be on stable immunosuppressive/renoprotective therapy. The trial aims to see if SGLT2 inhibitors can lower proteinuria, maintain remission, and reduce relapse, while monitoring kidney function and safety over 6 months. It is a single-center study led by Mansoura University with ongoing safety assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult patients (≥18 years). Biopsy-confirmed primary nephrotic syndrome (e.g., idiopathic membranous nephropathy, minimal change disease, focal segmental glomerulosclerosis).

Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m² using CKD-EPI formula.

On stable dose of immunosuppressive therapy and renoprotective agents for ≥4 weeks prior to randomization.

Able to signed informed consent.

Exclusion Criteria:

Diagnosis of secondary nephrotic syndrome as : diabetes mellitus, lupus nephritis, and amyloidosis.

* Impaired liver functions (ALT or AST values exceeding 3 folds upper limit of normal (ULN) at the screening visit).
* Glomerular hematuria (red blood cells more than ten cells per high power field (HPF) after routine urinalysis for more than three times in the last 2 weeks).
* History of severe hypersensitivity or contraindications to dapagliflozin or empagliflozine.
* Pregnancy or breastfeeding.

Where it's running

• Urology & Nephrology Center, Mansoura University
  Al Mansurah, Dakahlia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Maged S Hariz, PhD Candidate
• Email: dr.m.s.binhariz85@gmail.com
• Phone: 00201029837454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.