EUCTR2011-002150-31-FI进行中（未招募）1 期
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
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
- •Girls and boys between birth and < 1 year of age at the time of enrollment
- •Body weight = 3 kg at screening and enrollment
- •Diagnosis of CKD stage 3 to 5 with an estimated GFR < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
- •Hemoglobin = 9.0 g/dL within 7 days prior to enrollment
- •Transferrin saturation (TSAT) = 20% at screening
- •Clinically stable and suitable for participation in this study, in the judgment of the Investigator
- •Subject’s parent or legally acceptable representative (SPoLAR) has provided informed consent prior to performing any study-specific procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •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
- •Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother’s last menstrual period)
- •Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
- •History of cardiovascular events or thromboembolism
- •History of upper or lower GI bleeding
- •History of seizures
- •Active liver disease or history of liver disease
- •Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the
- •99th percentile + 5 mmHg for a subject’s age. Refer to Blood Pressure Stages defined in the The Fourth Report on the Diagnosis, Evaluation, and Treatment of
- •High Blood Pressure in Children and Adolescents” Pediatrics 2004
- •Major surgery 12 weeks prior to enrollment
- •Red blood cell transfusions 12 weeks prior to enrollment
- •Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment
- •Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment
- •Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as = 0.5 mg/kg per day prednisone or equivalent for = 5 days)
- •Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to
- •Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment
- •Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients
研究者
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