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SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

RecruitingPhase 2, Phase 3

Sponsor: Mansoura University

Conditions: Nephrotic Syndrome

Interventions: Dapagliflozin, Empagliflozin, Standard Therapy

Countries: Egypt

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Al Mansurah, Dakahlia Governorate, Egypt