Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
研究概览
简要总结
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
详细描述
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes
- •Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
- •Serum creatinine level: =<2.5 mg/dl
- •Patients aged 20-75 years
排除标准
- •Type 1 diabetes
- •Hereditary diabetes or secondary diabetes
- •Non-diabetic nephropathy
- •Familial hypercholesterolemia
- •Secondary hypertension
- •Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
- •Malignant tumor or life threatening disease
- •History of angioedema
- •Patients undergoing LDL apheresis
- •Biliary system obstruction or severe liver injury
- •Liver dysfunction
- •Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
- •Pregnant or nursing patients
- •Others: patients who are not suitable for this trial
研究组 & 干预措施
Intensive multifactorial therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
干预措施: Intensive multifactorial therapy (Other)
Standard therapy (Protocol A)
Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female.
干预措施: Standard therapy (Other)
Intensive multifactorial therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
干预措施: Intensive multifactorial therapy (Other)
Standard therapy (Protocol B)
Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
干预措施: Standard therapy (Other)
结局指标
主要结局
Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
时间窗: 5 years
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A
时间窗: 5 years
次要结局
- Cardiovascular event in Protocol A(5 years)
- Progression of retinopathy in Protocol A(5 years)
- Urinary albumin/creatinine ratio in Protocol A(5 years)
- Proteinuria (24 h collection sample) in Protocol A(5 years)
- Cardiovascular event in Protocol B(5 years)
- Progression of retinopathy in Protocol B(5 years)
- GFR in Protocol A(5 years)
- GFR in Protocol B(5 years)
- Urinary protein/creatinine ratio in Protocol B(5 years)
- Urinary albumin/creatinine ratio in Protocol B(5 years)
研究者
Kenichi Shikata
Professor
Okayama University