SGLT 2 Inhibitors, Pediatric Kidney Disease, Proteinuric Diseases, Dapagliflozin (Forxiga)
Conditions
Keywords
Pediatric kidney disease, Safety and efficacy, Kidney function biomarkers, Renal protection, Proteinuria, Dapagliflozin, Pediatric nephrology, SGLT2 inhibitors
Brief 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.
Interventions
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.
Sponsors
Al-Quds University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 4-18 years * Persistent proteinuria \> 500 mg/day despite standard therapy. * Stable renal function (eGFR ≥ 30 mL/min/1.73 m²). * Ability to comply with follow-up visits and study procedures. * Written informed consent obtained from parents or legal guardians, and assent from the patient when appropriate.
Exclusion criteria
* Known hypersensitivity or contraindication to dapagliflozin or other SGLT2 inhibitors. * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis. * Active urinary tract infection, severe dehydration, or hypotension. * Participation in another clinical trial within the last 30 days. * Any comorbid condition or medical history that, in the investigator's opinion, would interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of 24-hour proteinuria/m² before and after Dapagliflozin | Baseline to 12 months |
| Comparison of eGFR before and after Dapagliflozin | Baseline to 12 months |
Countries
Palestinian Territories
Outcome results
None listed