NCT02228655终止早期 1 期
An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in hemoglobin concentration
研究概览
简要总结
FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a documented hemoglobin level to be less than 10 g/dL at screening
- •diagnoses of CKD 4 or 5
- •body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height and weight at screening
- •ferritin levels ≥100 ng/ml or Tsat ≥20% at screening
- •erythropoietin (EPO) level greater than 8 ng/mL
- •able to provide written informed consent
- •able to understand and follow all trial procedures
- •willing to use contraception as detailed in the protocol
排除标准
- •receipt of red blood cell (RBC) transfusion within four weeks before screening
- •overt gastrointestinal bleeding or other bleeding episode that required transfusion within 2 months prior to screening
- •infection necessitating antibiotic or anti-viral treatment within a month prior to screening
- •requiring Coumadin (warfarin), Pradaxa®, Eliquis®, or Xarelto®
- •hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types
- •active hemolysis or chronic hypoxia
- •active malignant diseases (except non-melanoma skin cancer) or life expectancy less than 6 months
- •chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute infection
- •on immunosuppressive therapeutics except topical corticosteroids or nasal sprays
- •chronic congestive heart failure (New York Heart Association Class III, IV)
- •significant hypertension (≥90 diastolic) based on a sitting diastolic blood pressure at screening
- •kidney transplant within the past year: patients who are off immunosuppressive agents following a failed transplant are eligible for the trial
- •end-stage liver disease
- •known hypersensitivity to recombinant protein therapies
- •female patients who are pregnant or breast feeding
- •previous exposure to FMX-8
- •previous exposure to Epogen®, Procrit® (erythropoietin) Aranesp® (darbepoietin alpha), Omontys® or Hematide® (peginesatide) anemia treatment
- •uncontrolled hyperparathyroidism (PTH >750) based upon latest PTH determination within the past 4 months
- •inability to comply with the trial scheduled visits
研究组 & 干预措施
FMX-8
Other
FMX-8 for injection, 15mg/kg, twice weekly, 29 days
干预措施: FMX-8 (Drug)
结局指标
主要结局
Change in hemoglobin concentration
时间窗: 57 day evaluation period
次要结局
未报告次要终点
研究者
研究点 (1)
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