NCT06226896进行中（未招募）不适用
Effects of Dapagliflozin on Progression of Alport Syndrome
Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2023年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Change of eGFR
研究概览
简要总结
Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or genetic confirmation of Alport syndrome;
- •eGFR ≥ 30 ml/min/1.72m2;
- •Proteinuria > 0.5 g/24 h;
- •Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;
排除标准
- •Concurrence of other types of kidney disease;
- •type 1 or type 2 diabetes;
- •use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
- •ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
- •Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
- •Patients undergoing renal transplantation or maintenance dialysis treatment;
- •Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases;
- •Patients who are participating in clinical trials of other drugs;
- •Pregnant or lactating women, or patients who do not want to receive contraception.
研究组 & 干预措施
Dapagliflozin + RAS inhibitor
In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Change of eGFR
时间窗: 24 months
The change of eGFR from baseline after 24 months of treatment
次要结局
- Change of proteinuria(24 months)
- Progression of kidney disease(24 months)
研究者
Zhi-Hong Liu, MD
Prof.
Nanjing University School of Medicine
研究点 (1)
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