Status:
NOT_YET_RECRUITING
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
Lead Sponsor:
Mansoura University
Conditions:
Nephrotic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
This randomized, controlled, open-label, single-center clinical trial is designed to investigate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically dapagliflozi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 6 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07214818
Start Date
November 15 2025
End Date
September 6 2026
Last Update
October 9 2025
Active Locations (1)
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1
Urology & Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt, 35516