Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
研究概览
简要总结
To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.
详细描述
Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.
In normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 to 70 yrs of age of either sex.
- •CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.
- •Patients who are willing to give the consent
- •Patient with Anemia of Chronic Renal Failure with Hb < 10.
排除标准
- •Patients who are known hypersensitive to rHu-EPO.
- •Patient's with history of anemia due to causes other than anemia of CRF.
- •Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.
- •Patient's with history of G.I. bleeding (Overt or Occult).
- •Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.
- •Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.
- •Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.
- •Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients
结局指标
主要结局
Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
OR
Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
次要结局
- Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.