Efficacy and Safety of Dapagliflozin in Children With Proteinuria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Comparison of 24-hour proteinuria/m² before and after Dapagliflozin
研究概览
简要总结
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.
详细描述
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:
- Change in 24-hour proteinuria/m² before and after dapagliflozin therapy.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy (Drug)
结局指标
主要结局
Comparison of 24-hour proteinuria/m² before and after Dapagliflozin
时间窗: Baseline to 12 months
Comparison of eGFR before and after Dapagliflozin
时间窗: Baseline to 12 months
次要结局
未报告次要终点