RPCEC00000077已完成3 期
Therapeutic Equivalence between ior EPOCIM and EPO without albumin, for patients with Chronic Renal failure on Peritoneal dialysis methods.(Hemodialysis or peritoneal dialysis).
Center of Molecular Inmunology(CIM)0 个研究点目标入组 60 人开始时间: 2009年7月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 70 years(—)
- 性别
- All
入选标准
- •1.Patients who have given their consent to participate in the study in writing. 2.Patients aged between 18 and 70 years. 3.Treatment with stable dialysis patients for a minimum period of 6 months. 4.Patients who have received ior EPOCIM for the treatment of anemia associated with CRF and maintain levels equal to or greater than 30% of hematocrit and hemoglobin equal to or greater than 10g/dL with a stable dose of EPOCIM for 3 months. 5.Includes patients of both sexes in the study.
排除标准
- •1.Pregnant patients,nursing or women of childbearing age who are not using contraception. 2.Patients with uncontrolled arterial hypertension. 3.Patients receiving treatment with immunosuppressive agents. 4.Patients with a history of epilepsy. 5.Patients with sepsis or active infection. 6.Patients with active acute or chronic inflammatory. 7.Patients who have been transfused in the month prior to the assessment for inclusion. 8.Patients with hematologic diseases. 9.Patients with Severe Hyperparathyroidism. 10.Patients with a diagnosis of malignancy or therapy Anticancer. 11.Renal transplant patients scheduled to coincide with period of study. 12.Patients with known hypersensitivity to products derived from mammalian cells. 13.Psychiatric patients with decompensated. 14.Patients with alcoholism or drug addiction.
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