A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour urinary albumin excretion
研究概览
简要总结
The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.
详细描述
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- Triple (Participant, Care Provider, 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
- •Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria), and treated with oral antidiabetic drugs
- •Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
- •Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2)
- •Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
- •Fasting plasma glucose less than 270 mg/dL at screening
排除标准
- •Type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Previous renal transplant or known non-diabetic renal disease, except related to hypertension
- •Undergone renal dialysis at any time in the past
- •Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
- •Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
- •Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
- •Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
- •Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)
研究组 & 干预措施
Placebo (Group A)
干预措施: Placebo (Drug)
Active study medication (Group B)
CCX140-B
干预措施: CCX140-B (Drug)
结局指标
主要结局
Change from baseline in 24-hour urinary albumin excretion
时间窗: 84 days
The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.
Subject incidence of adverse events
时间窗: 84 days
The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.
次要结局
- Change from baseline in hemoglobin A1c(84 days)