An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 39
- 主要终点
- Change in Average Hb Concentration Between Baseline and Evaluation Period
研究概览
简要总结
This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
- •Hemodialysis for greater than or equal to (>=) 8 weeks
- •Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >= 25 percent (%) (increase or decrease) during the 2 weeks of screening
排除标准
- •Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- •Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
- •Active malignant disease
- •Pure red cell aplasia (PRCA) or history of PRCA
- •Pregnant or lactating females
- •Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment
研究组 & 干预措施
MIRCERA Group 1: Intermediate-Conversion-Factor Group
Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 * previous weekly epoetin dose [international units {IU}]/250 or 4 * previous weekly darbepoetin alfa dose [micrograms {mcg}]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.
干预措施: Methoxy Polyethylene Glycol-Epoetin Beta (Drug)
MIRCERA Group 2: High-Conversion-Factor Group
Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 * previous weekly epoetin dose [IU]/125 or 4 * previous weekly darbepoetin alfa dose [mcg]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.
干预措施: Methoxy Polyethylene Glycol-Epoetin Beta (Drug)
结局指标
主要结局
Change in Average Hb Concentration Between Baseline and Evaluation Period
时间窗: Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)
A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.
次要结局
- Number of Participants With Blood Transfusions(Baseline to Week 20)
- Change in Average Reticulocyte Count Between the Baseline and Evaluation Period(Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21))
- Maximum Observed Serum Concentration (Cmax) of MIRCERA(Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13)
- Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA(Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13)
- Time to Reach Cmax (Tmax) of MIRCERA(Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13)
- Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb(Evaluation Period (Week 17 to Week 21))
- Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL(Evaluation Period (Week 17 to Week 21))
- Apparent Terminal Phase Half-Life (t1/2) of MIRCERA(Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13)