A Single-Arm Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin 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
- 163
- 主要终点
- Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
研究概览
简要总结
This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. 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
- •adult patients, >=18 years of age;
- •chronic renal anemia;
- •hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- •stable maintenance epoetin alfa therapy for past 2 months.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
- •acute or chronic bleeding during previous 2 months.
研究组 & 干预措施
C.E.R.A
Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter
时间窗: EEP (Week 16 to 24)
The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant's all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).
次要结局
- Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP(SVP (Week -4 to -1), EEP (Week 16 to 24))
- Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP(EEP (Week 16 to 24))
- Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP(EEP (Week 16 to 24))
- Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP(EEP (Week 16 to 24))
- Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP(Baseline (Week 0) to Week 24)
- Mean Monthly Dose of C.E.R.A During the DTP and EEP(Baseline (Week 0) to Week 24)
- Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase(Baseline (Week 0) to Week 44)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to Week 52)
- Mean Haemoglobin Levels Over Time(Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- Mean Hematocrit Levels Over Time(Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48)
- Mean White Blood Cells and Thrombocyte Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)
- Mean Phosphate and Potassium Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)
- Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)
- Mean Transferrin Saturation Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)
- Mean Albumin and Transferrin Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)
- Mean C-Reactive Protein Levels Over Time(Baseline (Week 0), 8, 16, 24, 32, 40, and 48)
- Mean Ferritin Levels Over Time(Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48)