NCT00491868已完成3 期
Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).
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
- 134
- 试验地点
- 5
- 主要终点
- Variation of Hb concentration from baseline Hb concentration in evaluation period
研究概览
简要总结
This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 3 times a week for at least 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 week for at least 8 weeks before registration
- •Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.
- •Patients whose pre-dialysis Hb concentrations has been between ≥ 9.0 g/dL and ≤12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between ≥ 9.5 g/dL and ≤11.5 g/dL determined at the beginning of each week within 8 weeks before registration
- •Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any 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 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, testosterone propionate, methyltestosterone 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 subinvestigator
研究组 & 干预措施
1
Experimental
干预措施: rHuEPO placebo (Drug)
1
Experimental
干预措施: R744 (Drug)
2
Experimental
干预措施: R744 (Drug)
2
Experimental
干预措施: rHuEPO placebo (Drug)
3
Active Comparator
干预措施: rHuEPO (Drug)
3
Active Comparator
干预措施: R744 placebo (Drug)
4
Active Comparator
干预措施: rHuEPO (Drug)
4
Active Comparator
干预措施: R744 placebo (Drug)
结局指标
主要结局
Variation of Hb concentration from baseline Hb concentration in evaluation period
时间窗: week 17~24
次要结局
- Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of ≥ 9.0g/dL and ≤ 12.0g/dL in evaluation period(week 17~24)
- Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb(week 17~24)
- Adverse events(throughout study)
- Anti-R744 antibody titer(throughout study)
- Anti-Epoetin beta antibody titer(throughout study)
- Laboratory measurements(throughout study)
- Vital signs, standard 12-lead ECG(throughout study)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
3 期
Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)Predialysis PatientsNCT00492427Chugai Pharmaceutical187
已完成
2 期
Safety of SonoVue on Pulmonary HemodynamicsPulmonary HypertensionNCT01306292Bracco Diagnostics, Inc36
招募中
不适用
Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.Esophageal NeoplasmsHead and Neck NeoplasmsGastrointestinal NeoplasmsDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesNeoplasms by SiteGastrointestinal DiseasesNeoplasmsNCT06365866Taipei Veterans General Hospital, Taiwan20
招募中
1 期
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple SclerosisMultiple SclerosisNCT05532943Ever Supreme Bio Technology Co., Ltd.41
已完成
3 期
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal OsteoporosisPost Menopausal OsteoporosisNCT00048074Hoffmann-La Roche1,395