TCTR20140128002招募中4 期
An open-label prospective study to evaluate the efficacy and safety of a recombinant human Erythropoietin (Hema-Plus) for the management of anemia in patients on peritoneal dialysis
Apexcela, Co., Ltd.0 个研究点目标入组 30 人开始时间: 2014年1月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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 70 Years（—）
- 性别
- All
入选标准
- •1.Patients who have consented to participate in the study in writing
- •2.Patients with chronic renal disease whose GFR is less than 15 ml/min/1.73 m2 and are identified to start peritoneal dialysis
- •3.Age between 18-70 years on the day of consent
- •4.Hemoglobin < 9.5 g/dL
- •5.Serum ferritin level > 100 ng/ml and serum transferrin saturation (TSAT) > 20%
排除标准
- •Main exclusion criteria
- •1.Patients who have previously used Epoetin
- •2.Patients who are pregnant or breastfeeding or women of childbearing potential who are not willing to use an effective method of birth control
- •3.Participation in any drug trial in which the patient received an investigational drug within 3 months prior to screening visit.
- •4.Patients who have the underlying conditions
- •-had blood transfusion within 8 weeks prior to screening visit
- •-Poorly controlled hypertension with diastolic blood pressure greater than 110 mmHg at screening visit.
- •-History of seizure disorder
- •-Previous diagnosis with malignant tumor or patients who had residual tumor after anti-cancer therapy elicited by medical history
- •-Patients with signs and symptoms or laboratory assessment associated with EPO-resistant bone marrow disease such as aplastic anemia, myelodysplastic syndrome, myelofibrosis, myelopthistic anemia or Pure Red Cell Aplasia (PRCA)
- •-Known hypersensitivity to the mammalian cell-derived product or human albumin products
- •5.Patients who are using concomitant androgens or immunosuppressive therapy
- •6. Patients who have Secondary hyperparathyroidism as evaluated by serum parathyroid hormone (PTH) level greater than 800 pg/ml at screening
研究者
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