A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
研究概览
简要总结
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 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
- •adult patients >=18 years of age;
- •chronic renal anemia;
- •regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
- •continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease (except non-melanoma skin cancer).
研究组 & 干预措施
C.E.R.A.
Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL.
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 Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
时间窗: EEP (Week 17 to Week 24)
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
次要结局
- Number of Participants With Any Adverse Events or Serious Adverse Events(Up to Week 52)
- Mean Hematocrit Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Albumin Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Weight Over Time(Week 16 and Week 48)
- Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP(DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24))
- Mean Hemoglobin Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period(SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24))
- Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP(EEP (Week 17 to Week 24))
- Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase(Up to Week 52)
- Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP(EEP (Week 17 to Week 24))
- Mean Phosphate and Potassium Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean White Blood Cells and Thrombocytes Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean C-Reactive Protein Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Ferritin Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Transferrin Saturation Levels Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Pulse Rate Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)
- Mean Change From Baseline in Blood Pressure Over Time(Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48)