DOUBLE PRO-TECT Alport: a Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients with Alport Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 16
- 主要终点
- Primary endpoint
研究概览
简要总结
Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blinded study using capsules.
入排标准
- 年龄范围
- 10 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dapagliflozin
Dapagliflozin (standard dose 10 mg p.o. once daily).
干预措施: Dapagliflozin (Drug)
Placebo
Placebo therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Primary endpoint
时间窗: 48 weeks
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks
次要结局
- Key secondary safety endpoint(52 weeks)
- Adverse events (AE) of special interest(52 weeks)
- Key secondary efficacy endpoint(52 weeks)
研究者
Prof. Dr. O. Gross
Prof. Dr. Oliver Gross
University Hospital Goettingen