A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 17
- 主要终点
- Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
研究概览
简要总结
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- •male or female patients, >=18 years of age;
- •chronic renal anemia;
- •Hb concentration 10.5g/dL - 12.5g/dL;
- •continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
排除标准
- •blood transfusion within the previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease;
- •congestive heart failure (NYHA Class IV).
研究组 & 干预措施
Mircera
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
时间窗: Weeks 8 to 12 (Last 4 weeks of treatment period)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
次要结局
- Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time(At Weeks -2, 4, 8, and 12)
- Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)(SVP (Weeks -2 to -1) and TP (Weeks 8 to 12))
- Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL(Up to Week 12)
- Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths(Up to Week 14)
- Mean Change From Baseline in Heart Rate Over Time(From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12)
- Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time(From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12)
- Number of Participants With Abnormal Electrocardiogram(At Week -2 and Week 12)
- Mean Values of Serum Albumin and Serum Globulin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of White Blood Cells and Platelets Over Time(At Weeks -2, 4, 8, and 12)
- Mean Corpuscular Volume Levels Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Sodium and Serum Potassium Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Hypochromic Red Blood Cells Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Ferritin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Transferrin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Transferrin Saturation Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time(At Weeks -2, 4, 8, and 12)