EUCTR2006-003173-27-FR进行中（未招募）1 期
A Multi-Center, Single Arm Study Evaluating De Novo Once Monthly (QM) Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects with Chronic Kidney Disease (CKD) Not Receiving Dialysis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 155
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
- •= 18 years of age
- •Estimated GFR of = 15 mL/min/1.73 m2 - = 60 mL/min/1.73 m2 (MDRD equation)
- •Clinically stable, in the judgment of the investigator
- •The mean of 2 screening Hb values taken at least 7 days apart must be <11.0 g/dL
- •Adequate iron stores (serum ferritin > 100 µg/L)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Scheduled to receive a kidney transplant
- •ESA use within 12 weeks before enrollment
- •Uncontrolled hypertension defined as diastolic BP > 110 mm Hg or systolic BP >180 mm Hg
- •Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack within 12 weeks before enrollment
- •Major surgery within 12 weeks before enrollment (excluding vascular access
- •Currently receiving antibiotic therapy for systemic infection.
- •Known positive HIV antibody or positive hepatitis B surface antigen
- •Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
- •Red blood cell (RBC) transfusions within 8 weeks before enrollment
- •Androgen therapy within 8 weeks before enrollment
- •Systemic hematological disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia)
- •Any disorder that may impact (in the judgment of the investigator) the ability to give informed consent for participation in this study
- •Pregnant or breast-feeding women. All subjects must practice adequate
- •contraception (in the judgment of the investigator) throughout this study
- •Treatment with an investigational agent or device within 30 days before
- •enrollment or scheduled to receive an investigational agent other than those
- •specified by this protocol during the course of this study
- •Subject has known sensitivity to any of the products to be administered during dosing
- •Grand mal seizure within 6 months before enrollment
- •Upper or lower GI bleeding within 6 months before enrollment
- •Currently receiving immunosuppressive therapy
研究者
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