Active — Not RecruitingPhase 2/3

SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

Egypt75 participantsStarted 2025-11-15

Plain-language summary

This randomized controlled clinical trial aims to evaluate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin and empagliflozin) in adult patients with primary nephrotic syndrome. The study will compare three groups: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone. The primary objective is to assess whether SGLT2 inhibitors reduce proteinuria, maintain remission, and prevent relapse. Secondary objectives include evaluating effects on kidney function (eGFR, serum creatinine) and monitoring safety outcomes. Participants will continue their baseline standard care and will be followed for 6 months with regular clinical evaluations, laboratory tests, and adverse event monitoring.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

1. Change in Proteinuria (uPCR)

Timeframe: Baseline to 6 months

Change in TNF-α Levels

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT07214818

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-05