Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in urinary albumin creatinine ratio (UACR)
研究概览
简要总结
This study is randomized, controlled, parallel, prospective clinical study will be conducted on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will be recruited from Tanta University Hospital, Tanta, Egypt.
Accepted patients will be randomized into 2 groups as the following:
Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus niclosamide tablets 1 gram once daily for six months The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) after six months of treatment
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 diabetes mellitus at least 5 years ago
- •Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) >30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
- •Hemoglobin A1c > 6.5 % with regular use of insulin and/or oral glucose lowering agents
排除标准
- •Type 1 diabetes mellitus
- •Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)
- •Pregnant or lactating women
- •Chronic heart failure
- •Inflammatory or autoimmune disease
- •History of kidney disease other than diabetic nephropathy
研究组 & 干预措施
Treatment group
Niclosamide tablets 1 gram once daily
干预措施: Niclosamide (Drug)
Control group
Lactose tablets
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in urinary albumin creatinine ratio (UACR)
时间窗: 6 months
Estimated glomerular filtration rate (eGFR)
时间窗: After 6 months
次要结局
- Change of Urinary matrix metalloproteinase-7 (MMP-7) level(6 months)
- Change of Urinary podocalyxin level(6 months)
研究者
Basma Mahrous El-Fatatry
Dr
Tanta University