An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range
研究概览
简要总结
This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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
- Randomized
- 干预模型
- Parallel
- 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, > or = 18 years of age;
- •kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
- •functioning graft of > 6 months and < 10 years after kidney transplantation, with no signs of acute rejection;
- •stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •need for dialysis therapy expected in next 6 months.
研究组 & 干预措施
CERA Treatment Once Monthly
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Darbepoetin Alfa Once Biweekly
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range
时间窗: Weeks 16-28
Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.
次要结局
- Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)(Baseline to 28 weeks)
- Percentage of Participants Needing Dose Adjustments(Up to 28 weeks)
- Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)(Weeks 16-28)
- Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)(Weeks 16-28)
- Incidence of RBC Transfusions(Up to 28 weeks)