NCT04755946Unknown3 期
Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 48
- 主要终点
- Percent change in urinary albumin creatinine ratio (UACR)
研究概览
简要总结
adding roflumilast to the standard therapy for diabetic nephropathy and studying the progression of many outcomes including urinary albumin to creatinine ratio, estimated GFR, biomarkers of diabetic nephropathy
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetic patients with persistent micro- or macroalbuminuria despite treatment with the maximum tolerated dose of ACE inhibitors for at least 8 weeks before the screening and randomization
- •Type I or II diabetic patient with stage 2 CKD (eGFR = 60 - 89 ml/min) ,stage 3 CKD (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min)
排除标准
- •moderate to severe hepatic disease (Child-Pugh B or C) severe renal disease (eGFR<15 ml/min) body-mass index below 25 kg/m2 concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) known psychiatric illness, congestive heart disease patients with allergy for roflumilast pregnant and lactating women
研究组 & 干预措施
roflumilast arm
Experimental
干预措施: Roflumilast (Drug)
placebo arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in urinary albumin creatinine ratio (UACR)
时间窗: Baseline and 3 months
measuring UACR pre and post experiment and substracting and dividing on baseline level
Absolute change in Estimated glomerular filtration rate (eGFR)
时间窗: Baseline and 3 months
substracting pre-treatment from post-treatment values of EGFR
次要结局
- Change in Urinary pro-inflammatory cytokine MCP-1(Baseline and 3 months)
- Change in serum irisin level(Baseline and 3 months)
研究者
Hisham Mohammad Abd-El-Galil El-Nahhas
Pharm D
Tanta University
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