NCT00913393终止2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- FibroGen
- 入组人数
- 46
- 主要终点
- Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
研究概览
简要总结
The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
详细描述
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Males and females 18-75 years of age, inclusive
- •Diagnosis of type 2 diabetes mellitus according to American Diabetes Association (ADA) criteria
- •24-hour urinary ACR 200-3000 mg/g, inclusive, on two occasions during screening at least 2 days apart
- •Estimated glomerular filtration rate (eGFR) (by MDRD equation) >20 mL/min/1.73 m2
- •Mean systolic blood pressure less than or equal to 150 mmHg and a mean diastolic blood pressure less than or equal to 95 mmHg
- •Receiving ACEi and/or ARB therapy at an unchanged dose at or above the minimum trial dosage for at least 3 months prior to the first Screening visit and willing to maintain these doses throughout the treatment period
排除标准
- •Females who are pregnant or breast feeding
- •Organ transplant recipient, history of dialysis, or known non-diabetic renal disease other than benign cysts or anatomical variants
- •History of New York Heart Association class III/IV heart failure
- •Screening electrocardiogram showing acute and/or clinically significant findings including but not limited to ST depression
- •History of any of the following events within 3 months prior to Screening: coronary artery bypass graft, cerebrovascular accident, myocardial infarction, transient ischemic attack, unstable angina, uncontrolled cardiac arrhythmia, atrial fibrillation, percutaneous coronary intervention, or vascular stent placement
- •History of anaphylactic or systemic allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the upper limit of normal; direct bilirubin above the upper limit of normal, or >2.5 times the upper limit of normal in cases of documented Gilbert's syndrome
- •Hemoglobin <10 g/dL
- •Hemoglobin A1c (HbA1c) >9 %
- •Low density lipoprotein (LDL) >130 mg/dL
研究组 & 干预措施
1
Placebo Comparator
Placebo IV
干预措施: Placebo (Drug)
2
Experimental
3 mg/kg FG-3019 IV
干预措施: FG-3019 (Drug)
3
Experimental
10 mg/kg FG-3019 IV
干预措施: FG-3019 (Drug)
结局指标
主要结局
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
时间窗: 6 months
次要结局
- Measure: Safety and tolerability of FG-3019 in the study population.(12 months)
- Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo(6 months)
- Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo(6 months)
研究者
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