EUCTR2008-003418-88-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Double-blind, Randomized Study Evaluating De Novo Weekly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 180
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
- •Signed informed consent form/assent form (if applicable)
- •Diagnosis of CKD defined as CKD stage 3 – 5, with an estimated Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2 (Schwartz equation) if not receiving dialysis, or: Receiving dialysis
- •Ages 1 year through 18 years
- •Two consecutive screening Hb values (taken at least 5 days apart during the screening period) must be < 10.0 g/dL
- •Transferrin saturation (Tsat) = 20%
- •Clinically stable and suitable for participation in this study, in the judgment of the investigator
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 208
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Anticipating or scheduled for a living related-donor kidney transplant
- •Prior history (within 12 weeks before randomization) of cardiovascular events including:
- •- acute myocardial ischemia
- •- hospitalization for congestive heart failure
- •- myocardial infarction
- •- stroke or transient ischemic attack
- •Hematologic disease that is likely to affect red blood cell production or turnover (eg, hemolytic anemia, thalassemia, sickle cell disease, myelodysplastic syndromes, hematologic malignancy); myeloma; hemolytic anemia; thalassemia
- •Upper or lower GI bleeding within the 6 months prior to randomization
- •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. See Appendix G.
- •(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)
- •Use of any erythropoiesis stimulating agent (ESA) within the 8 weeks prior to randomization, and/or, previous use of an ESA for an unapproved indication or administered via an unapproved route at any time prior to randomization
- •History of non-febrile seizure
- •Major surgery within 1 week prior to randomization (excluding vascular access surgery)
- •Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of localized basal cell or squamous cell carcinoma of the skin and cervical intraepithelial
- •RBC transfusions within 1 week prior to randomization
- •Androgen therapy within 8 weeks prior to randomization
- •Currently receiving antibiotic therapy for systemic infection
- •Prior history (within 6 months prior to randomization) of
- •thromboembolism (eg, deep vein thrombosis or pulmonary embolism)
- •Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to randomization
- •Pregnant or breast-feeding, or planning to become pregnant within four weeks after the end of treatment.
- •Females who have reached menarche must have a negative serum pregnancy test (or definitive evidence to
- •demonstrate lack of pregnancy) within 21 days prior to randomization, unless there is a documented
- •history of amenorrhea.
- •Not willing to use effective contraception during treatment and for 1 month after the end of treatment
- •Other investigational procedures are excluded
- •Treatment with an investigational product or device within 30 days before randomization or scheduled to receive an investigational product other than those specified by this protocol during the course of this
- •Has known sensitivity to any of the products to be administered during dosing
- •Subject or parent/legal guardian has any kind of disorder that compromises the ability of the subject or parent/legal guardian to give written informed consent and/or to comply with study procedures
- •Subject is receiving corticosteroids at a dose higher than 0.5 mg/kg body weight/day of prednis(ol)one (or equivalent dose of another steroid) for > 5 days within 4 weeks of enrollment. Subject is receiving any other immunosuppressive agent.
研究者
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