EUCTR2016-004779-39-FR进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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 willingness of parent/legal guardian to abide by the requirements of the study
- •- Written informed consent or assent from child where appropriate If required by national legislation, patients < 18 years of age at screening who are legally considered to be adults according to national legislation must consent in their own right
- •- Pediatric patients 3 months-17 years of age
- •- CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- •- For patients on PD: a weekly Kt/V >= 1.8
- •- For patients on hemodialysis (HD): adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for patients on HD three times per week
- •- Baseline hemoglobin (Hb) concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 and Visit 2
- •- 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
- •- For post-pubertal female patients of childbearing potential: agreement to remain abstinent or to use acceptable contraceptive methods during the study and for 90 days after the last dose of Mircera
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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 within 8 weeks before screening or during the screening period
- •- RBC transfusions within 8 weeks before screening or during the screening period
- •- Hemoglobinopathies
- •- 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
- •- 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 or biopsy-proven bone marrow fibrosis
- •- 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
- •- Planned elective surgery during the entire study period
- •- Females who are pregnant or breastfeeding or who intend to become pregnant during the study or within 90 days after the last dose of Mircera
- •- Patients of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study drug
研究者
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