NCT00754143已完成1 期
A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 38
- 主要终点
- Safety and tolerability of FG-3019
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, inclusive
- •Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
- •First morning urinary ACR >0.200 g/g
- •Receiving stable doses of ACEi and/or ARB therapy prior to Screening
- •Estimated glomerular filtration rate of ≥20 and <90 mL/min/1.73 m2
- •Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
- •Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization
排除标准
- •Female subjects who are pregnant or breastfeeding
- •Organ transplant recipient, previous dialysis, or non-diabetic renal disease other than benign cysts or anatomical variants
- •Any history of New York Heart Association (NYHA) class III/IV heart failure (HF)
- •Screening electrocardiogram showing acute, clinically significant findings including but not limited to ST depression
- •Recent history of serious heart problems (e.g. coronary artery bypass graft, cerebrovascular accident, or myocardial infarction)
- •History of cancer in the past 5 years, possibly excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
- •History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
- •Participation in other studies of investigational drugs at the time of Screening AND receipt of an investigational drug within 42 days prior to Screening
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal
- •Hemoglobin <10 g/dL
- •Positive for HIV (IgG) antibody
研究组 & 干预措施
A
Placebo Comparator
Placebo
干预措施: FG-3019 (Drug)
B
Experimental
FG-3019 5 mg/kg
干预措施: FG-3019 (Drug)
C
Experimental
FG-3019 10 mg/kg
干预措施: FG-3019 (Drug)
结局指标
主要结局
Safety and tolerability of FG-3019
时间窗: 34 weeks
次要结局
- Change from baseline in first morning urinary albumin creatinine ratio (ACR)(6 weeks (10 mg/kg) or 10 weeks (5 mg/kg))
- Pharmacokinetic parameters(34 weeks)
研究者
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