An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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, >=18 years of age;
- •chronic kidney disease, not requiring dialysis;
- •receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.
排除标准
- •overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
- •transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
- •active malignant disease;
- •previous treatment with Mircera.
研究组 & 干预措施
Mircera
Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
干预措施: Mircera (Drug)
Darbepoetin alfa
Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
时间窗: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
次要结局
- Change in Hemoglobin Concentration From Baseline Over Time(From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.)
- Number of Participants With Red Blood Cell (RBC) Transfusions(From randomization to Month 9)
- Participants With Adverse Events(Randomization to Month 10 (final visit))