Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
Lead Sponsor:
Al-Quds University
Conditions:
SGLT 2 Inhibitors
Pediatric Kidney Disease
Eligibility:
All Genders
4-18 years
Phase:
NA
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 change...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07204743
Start Date
August 15 2025
End Date
August 1 2026
Last Update
October 2 2025
Active Locations (1)
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1
Al Ahli hospital
Hebron, Palestine, Palestinian Territories, P700