NCT00433615已完成3 期
Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Ratio of Maintenance of target Hb concentration
研究概览
简要总结
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≥ 30 mL /min at any one time point within 12 weeks before registration
- •Patients aged ≥ 20 years at the time of obtaining consent
- •Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
- •Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and <13.0 g/dL
- •Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration
排除标准
- •Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions within 12 weeks before registration)
- •Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification)
- •Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure in the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug
- •Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
- •Patients who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been > 12.0 g/dL
- •ⅰ)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
- •ⅱ)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment )
- •ⅲ)Patients with congestive cardiac failure (≥ Class II in Fontaine arteriosclerosis obliterans classification)
- •Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom)
- •Patients hypersensitive to a rHuEPO preparation
- •Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage
- •Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration
- •Patients who have received another investigational drug within 12 weeks before registration
- •Patients who have received R744 before registration
- •Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration
- •Patients who have received erythrocyte transfusion within 16 weeks before registration
- •Patients for whom a surgical operation accompanied by marked bleeding is planned during the study period
- •In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
研究组 & 干预措施
1
Experimental
干预措施: R744 (Drug)
2
Experimental
干预措施: R744 (Drug)
结局指标
主要结局
Ratio of Maintenance of target Hb concentration
时间窗: 24th and 48th week
次要结局
- Slope of regression line of Hb concentration (g/dL/week)(24th week)
- Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL(24th week)
- Ratio of Maintenance of Hb concentration(24th and 48th week)
- Adverse events(24th and 48th week)
- Laboratory measurements(24th and 48th week)
- Vital signs, standard 12-lead ECG(24th and 48th week)
- Anti-R744 antibody titer(24th and 48th week)
研究者
研究点 (6)
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