Efficacy and Safety of Dapagliflozin in Children With Proteinuria

Sponsor
Al-Quds University
Study ID
NCT07204743
Status
Active Not Recruiting

Conditions

  • Dapagliflozin (Forxiga)
  • Pediatric Kidney Disease
  • Proteinuric Diseases
  • SGLT 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
4 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy — DRUG
    Participants will receive dapagliflozin, an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor, administered once daily at a dose of 5-10 mg. The intervention is intended to reduce proteinuria and provide nephroprotection in pediatric patients with kidney disease. Patients will be followed monthly, with monitoring of renal function markers (serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate) and 24-hour urinary protein excretion normalized to body surface area, in addition to safety outcomes such as hypoglycemia, dehydration, and urinary tract infections.

Study Details

This interventional study investigates the efficacy of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in pediatric patients with renal disease. The primary outcomes include changes in 24-hour proteinuria indexed to body surface area (mg/m²/day) and glomerular filtration rate (GFR) before and after dapagliflozin administration. By closely monitoring these parameters, the study aims to assess the renal protective potential of dapagliflozin in children and adolescents.

Key Dates

Start date
Aug 15, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Treatment Arm
    This arm includes pediatric patients with kidney disease who receive dapagliflozin (5-10 mg daily) as an adjunct therapy. Participants are monitored monthly to assess efficacy and safety outcomes. Key renal function parameters measured include serum creatinine (Cr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and 24-hour urinary protein excretion normalized to body surface area. Additional markers such as blood pressure, metabolic status, and potential adverse events (e.g., hypoglycemia, dehydration, urinary tract infections) are also evaluated. The purpose of this arm is to determine the effect of dapagliflozin on reducing proteinuria and improving renal outcomes in the pediatric population.

Primary Outcome Measure

Comparison of 24-hour proteinuria/m² before and after Dapagliflozin [ Time Frame: Baseline to 12 months ]

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