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SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllMansoura University
NCT07214818 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dapagliflozin
  • Empagliflozin
  • Standard Therapy
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Where

1 site
Urology & Nephrology Center, Mansoura University
Al Mansurah, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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