TCTR20140212001已完成4 期
Comparative Efficacy and Safety Study between Lyophilized power of Alpha-Erythropoietin and Alpha-Erythropoietin Reference Product for Hemoglobin Maintenance in Patients with Hemodialysis
Phramongkutklao Hospital and College of Medicine0 个研究点目标入组 44 人开始时间: 2014年2月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •age, 18 years or older, treatment with hemodialysis for at least three months, and a single pool Kt/Vurea of 1.2 or greater per dialysis treatment, adequate iron status (≥20% of transferrin saturation and ≥100 ng/mL of ferritin) and stable hemoglobin level of 10-12 g/dL with standard reference EPO alpha biological product (EPREX®) treatment at least 3 months.
排除标准
- •patients with identify causes of anemia such as gastrointestinal hemorrhage, hematologic malignancy, chronic infection, and malnutritonal anemia, active malignancy, pregnancy, severe hyperparathyroidism indicated by a serum parathyroid hormone level >9x ULN, uncontrolled hypertension (mean systolic blood pressure > 180 or diastolic blood pressure > 110 mmHg), active epilepsy or seizure within 8 weeks before screening, and active infection or hospitalization within 3 months before screening.
研究者
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