NCT03552393已完成2 期
An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 22
- 主要终点
- Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
研究概览
简要总结
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.
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
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants 3 months to 17 years of age with clinically stable chronic renal anemia
- •CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (determined by the Bedside Schwartz formula) or dialysis treatment for at least 8 weeks before the first dose of Mircera
- •For participants on peritoneal dialysis (PD): a weekly Kt/V≥ 1.8
- •For participants on hemodialysis (HD): adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for participants on HD three times per week.
- •Participants with fewer than or more than three HD sessions per week should have a weekly Kt/V≥ 3.
- •Baseline Hb concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 (Week -3) and Visit 2 (Week -1)
- •Stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa with the same dosing interval for at least 6 weeks before the first dose of Mircera
- •Stable dose of epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change > 25% (increase or decrease) for at least 4 weeks before the first dose of Mircera
- •Adequate iron status defined as ferritin≥100 ng/mL or transferrin saturation (TSAT)≥ 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening.
排除标准
- •Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- •RBC transfusions within 8 weeks before screening or during the screening period
- •Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) Hemolytic anemia, Active malignant disease
- •PD subjects with an episode of peritonitis within the past 30 days prior to screening and/or during the screening period
- •Uncontrolled or symptomatic inflammatory disease (e.g., systemic lupus erythematosus)
- •Uncontrolled hypertension as assessed by the investigator
- •Epileptic seizures within 3 months prior to screening and during the screening period
- •Administration of any investigational drug within 4 weeks prior to screening or planned during the study
- •Severe hyperparathyroidism (intact parathyroid hormone [PTH]≥ 1000 pg/mL or whole PTH≥ 500 pg/mL) or biopsy-proven bone marrow fibrosis
- •Kidney transplant with use of immunosuppressive therapies known to exacerbate anemia
- •Known hypersensitivity to recombinant human erythropoietin (EPO), polyethylene glycol, or any constituent of the study drug formulation
- •Anti-EPO antibody (AEAB)-mediated pure red cell aplasia (PRCA) or history of AEAB mediated PRCA or positive AEAB test result in the absence of PRCA
- •High likelihood of early withdrawal or interruption of the study (e.g., planned living donor kidney transplant within 5 months of study start)
- •Planned elective surgery during the entire study period
研究组 & 干预措施
Mircera
Experimental
Mircera will be administered subcutaneously once every 4 weeks
干预措施: Mircera (Drug)
结局指标
主要结局
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
时间窗: Baseline up to Week 21
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
次要结局
- Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL(Week 17 up to Week 21)
- Mean Hb Values and Change From Baseline(Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45)
- Change in Mircera Dose Over Time(Week 1 to Week 17)
- Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17(Week 1, Week 17)
- Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade(Baseline up to Week 45)
- Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model(Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's convenience)
研究者
研究点 (22)
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