NCT03436693已完成3 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 25
- 主要终点
- Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Additional criteria check may apply for qualification:
- •Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%
- •eGFR of ≥30 mL/min/1.73m2 and <90 mL/min/1.73m2
- •The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr
- •Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
- •Patients who are under dietary management and taking therapeutic exercise for diabetes
排除标准
- •Additional criteria check may apply for qualification:
- •Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
- •A diagnosis of non-diabetic renal disease
- •Hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
- •Severe hepatic disorder or severe renal disorder
- •Blood potassium level >5.5 mmoL/L
- •Stable blood pressure (diastolic blood pressure (DBP) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)
研究组 & 干预措施
Canagliflozin 100mg
Experimental
干预措施: Canagliflozin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
时间窗: Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
次要结局
- Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104(Baseline and Week 104)
- Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death(up to approximately 108 weeks)
- Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104(Week 104)
- Change From Baseline in eGFR at Week 104(Baseline and Week 104)
研究者
研究点 (25)
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