Efficacy and Safety of Dapagliflozin in Children With Proteinuria

NCT07204743 | Active Not Recruiting

• 1 other identifier: 382738738
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric kidney disease; Safety and efficacy; Kidney function biomarkers; Renal protection; Proteinuria; Dapagliflozin; Pediatric nephrology; SGLT2 inhibitors

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Dapagliflozin Treatment Arm

EXPERIMENTAL

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.

Drug: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy

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.

Dapagliflozin Treatment Arm

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (1)

Al Ahli hospital

Hebron, Palestine, P700, Palestinian Territories

Location

Related Publications (1)

• Van Reeth O, Caliment A, de la Fuente Garcia I, Niel O. Safety Profile and Effectiveness of Dapagliflozin in Pediatric Patients with Chronic Kidney Disease. Am J Nephrol. 2024;55(4):463-467. doi: 10.1159/000539300. Epub 2024 May 14.

  PMID: 38735286 BACKGROUND

MeSH Terms

Conditions

Proteinuria

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bassil A Leghrouz, MD

  Al Ahli hospital-Palestine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 2, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)