NCT00433693已完成3 期
Correction Study of Intravenous Injections of R744 to Hemodialysis 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
- 50
- 试验地点
- 6
- 主要终点
- The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL
研究概览
简要总结
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 who have been receiving hemodialysis more than 1 time a week
- •Patients aged ≥ 20 years at the time of obtaining consent
- •After starting of hemodialysis, patients who have not received rHuEPO preparation
- •After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been < 10.0 g/dL
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 after starting of hemodialysis during the last week 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 during 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 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 involved with heavy 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)
结局指标
主要结局
The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL
时间窗: 26 weeks
次要结局
- Variation of QOL(26 weeks)
- Adverse events(26 weeks)
- Regression line of Hb concentration per week(26 weeks)
- Achievement rate of Hb concentration of ≥ 11.0 g/dL(26 weeks)
- dose transition of study drug(26 weeks)
- Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL(26 weeks)
- Laboratory measurements(26 weeks)
- Anti-R744 antibody titer(26 weeks)
- Transition of Hb concentration(26 weeks)
- Vital signs, standard 12-lead ECG(26 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)Hemodialysis PatientsNCT00433888Chugai Pharmaceutical179
未知
2 期
A study of intravenous R744 in renal anemia patients on hemodialysis.AnemiaJPRN-jRCT2080220218Chugai Pharmaceutical Co., Ltd.
已完成
3 期
Clinical Study of R744 to Peritoneal Dialysis PatientsPeritoneal Dialysis PatientsNCT00433849Chugai Pharmaceutical72
已完成
3 期
Clinical Study of R744 to Predialysis PatientsAnemia in Pre-Dialysis PatientsNCT00433615Chugai Pharmaceutical124
未知
3 期
Correction study of intravenous injections of R744 to Hemodialysis patients ( Phase III study ).Renal anemiaJPRN-jRCT2080220345Chugai Pharmaceutical Co., Ltd.