NCT02327754已完成2 期
Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in urine albumin creatinine ratio
研究概览
简要总结
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes patients
- •Clinically or pathologically diagnosed diabetic nephropathy
- •Hyperuricemic or gout patients
- •Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g
排除标准
- •Patient has known non-diabetic nephropathy (other than nephrosclerosis)
研究组 & 干预措施
Active comparator
Active Comparator
Topiroxostat, (Oral daily dosing for 28 weeks)
干预措施: Topiroxostat BID, (Oral daily dosing for 28 weeks) (Drug)
Placebo comparator
Placebo Comparator
Placebo, (Oral daily dosing for 28 weeks)
干预措施: Placebo BID, (Oral daily dosing for 28 weeks) (Drug)
结局指标
主要结局
Change from baseline in urine albumin creatinine ratio
时间窗: 28 weeks
次要结局
- sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC(28 weeks)
研究者
研究点 (1)
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