NCT07204743

Efficacy and Safety of Dapagliflozin in Children With Proteinuria

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Al-Quds University · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an interventional study designed to evaluate the effect of dapagliflozin, an SGLT2 inhibitor, on renal function in a pediatric population with underlying kidney disease. Eligible participants will include children and adolescents diagnosed with renal impairment. All participants will receive dapagliflozin at an appropriate pediatric dose and will be followed over the study period. Baseline assessments will include measurement of serum creatinine, blood urea nitrogen (BUN), electrolytes, 24-hour urine protein normalized to body surface area (mg/m²/day), and estimated glomerular filtration rate (eGFR). Follow-up evaluations will be conducted at regular intervals, with the same laboratory parameters measured to monitor both efficacy and safety. The primary endpoints are: 1. Change in 24-hour proteinuria/m² before and after dapagliflozin therapy. 2. Change in glomerular filtration rate (GFR) before and after treatment. Secondary endpoints will include trends in serum creatinine, BUN, electrolyte balance, and tolerability of dapagliflozin in this age group. Safety monitoring will be performed throughout the study to detect potential adverse effects, such as hypoglycemia, dehydration, or urinary tract infections. This study is expected to provide valuable evidence regarding the renal protective effects of dapagliflozin in pediatric patients, contributing to knowledge on its role as a novel therapeutic option in managing pediatric kidney disease.

Conditions

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

Interventions

Type	Name	Description
DRUG	Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy	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.

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: Palestinian Territories