NCT04534270已完成4 期
Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin
研究概览
简要总结
The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 years to 18 years;
- •Urinary protein excretion > 0.2g in a 24-hr urine collection;
- •eGFR≥60 ml/min/1.73m2;
- •No history of diabetes;
- •On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;
排除标准
- •Receiving immunosuppressive therapy within three months prior to enrolment.
- •Blood pressure less than 5th percentile of the same gender, age, and height -
- •Leukocyte and/or nitrite positive urinalysis that is untreated;
- •History of organ transplantation, cancer, liver disease;
- •Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
研究组 & 干预措施
Dapagliflozin treatment
Experimental
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin
时间窗: From baseline to weeks 4
Urine will be collected for 24 hours and total urinary protein will be detected
次要结局
- The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin(From baseline to weeks 12)
- The change in eGFR after a 12 weeks treatment with dapagliflozin(Measured at baseline, weeks 4, weeks 8, weeks 12)
研究者
Hong Xu，MD.PhD
Professer
Children's Hospital of Fudan University
研究点 (1)
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