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临床试验/TCTR20161214001
TCTR20161214001已完成4 期

Efficacy and Safety of Subcutaneous Administration of Lyophilized Powder of Alpha-Erythropoietin to Maintains Hemoglobin Concentrations among Hemodialysis Patients

Phramongkutklao hospital and College of Medicine0 个研究点目标入组 63 人开始时间: 2016年12月14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
63

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 85 Years(—)
性别
All

入选标准

  • Eligibility included male and female patients aged 18 to 85 years diagnosed with CKD receiving hemodialysis who presented stable hemoglobin levels of 10-11.5 g/dL with standard liquid EPO alpha product (EPREX, CILAG AG, Switzerland) treatment at least 12 weeks. All patients had adequate dialysis by a single pool Kt/Vurea greater than 1.2 per dialysis treatment and adequate iron status (≥20% of transferrin saturation and ≥200 ng/mL of ferritin).

排除标准

  • Patients were excluded from the study if they were on peritoneal dialysis or had identified causes of anemia such as gastrointestinal hemorrhage, hematologic malignancy, chronic infection and nutritional anemia. In addition, patients were excluded if they were hyporesponsive to EPO (defined as an intravenous EPO dose of >360 IU/kg weekly or an intravenous darbepoetin dose of >1.8 mg/kg weekly) within the prior 12 weeks.

研究者

发起方
Phramongkutklao hospital and College of Medicine

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