EUCTR2007-007758-70-HU进行中（未招募）不适用
An open-label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA® for maintenance treatment of anemia in pediatric patients with chronic kidney disease on hemodialysis. - DOLPHI
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- written informed consent from parent/legal guardian and/or assent from child where appropriate as required by national legislation
- •- children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia;
- •- hemodialysis for >=8 weeks;
- •- intravenous stable maintenance epoetin alfa, epoetin beta or darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >/=25% (increase or decrease) during the 2 weeks of screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 68
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;
- •- red blood cell (RBC) transfusions within 8 weeks before screening;
- •- active malignant disease;
- •- pure red cell aplasia (PRCA) or history of PRCA;
- •- pregnant or lactating;
- •- for sexually active patients: not willing to use reliable contraception.
研究者
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