SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

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 criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dapagliflozin
  • Empagliflozin
  • Standard Therapy

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators