NCT04224428已完成3 期
Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease
适应症
干预措施
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
- Percent change in urinary albumin creatinine ratio (UACR)
研究概览
简要总结
- This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus.
- Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt.
This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following
- Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months
- Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months
The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 18 years
- •Confirmed diagnosis of Type 2 diabetes mellitus at least 6 months prior to screening
- •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
- •Malignancy
- •Inflammatory or autoimmune disease
- •History of kidney disease other than diabetic nephropathy
研究组 & 干预措施
Control group
Placebo Comparator
干预措施: Placebo oral tablet (Drug)
Fexofenadine group
Active Comparator
干预措施: Fexofenadine Pill (Drug)
结局指标
主要结局
Percent change in urinary albumin creatinine ratio (UACR)
时间窗: After 6 months
次要结局
- Urinary monocyte chemoattractant protein-1 (MCP-1)(After 6 months)
- Urinary cyclophilin A(After 6 months)
研究者
Basma Mahrous El-Fatatry
Principal investigator, Assistant lecturer of Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
Tanta University
研究点 (1)
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