SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

Sponsor
Mansoura University
Study ID
NCT07214818
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Nephrotic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg PO once daily for 6 months
  • Empagliflozin — DRUG
    Empagliflozin 10 mg PO once daily for 6 month
  • Standard Therapy — OTHER
    immunosuppressive therapy and renoprotective agents for 6 months

Study Details

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.

Key Dates

Start date
Nov 15, 2025
Status verified
Jun 2026
Primary completion
Jul 5, 2026
Completion
Sep 6, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin + Standard of Care
  • Experimental: Empagliflozin + Standard of Care
  • Active Comparator: Standard of Care Only
    Standard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor.

Primary Outcome Measure

1. Change in Proteinuria (uPCR) [ Time Frame: Baseline to 6 months ]

Central Contacts

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