CTRI/2008/091/000257已完成3 期
A Multicentric, prospective, phase III clinical study to evaluate the efficacy and safety of Zydus Recombinant Human Epoetin Alpha (r-HuEPO) in maintaining haemoglobin level in Chronic Renal Failure (CRF). - EPO.08.001.01.1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
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
入选标准
- •1.Medically stable CRF patients of either gender with age ≥ 18 years.
- •2.History of EPO alpha therapy for at least 6 weeks at the time of enrolment.
- •3.Haemoglobin level more than or equal to 9 g/dL.
- •4.Given written informed consent for participating in the trial.
排除标准
- •1.Pregnancy or nursing mothers.
- •2.History of adverse drug reaction related with EPO alpha treatment.
- •3.History of uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or Systolic blood pressure; more than or equal to 180 mm Hg) despite at least one anti-hypertensive therapy during past three weeks.
- •4.Clinically unstable patients in the judgement of the investigator [immediate post-myocardial infarction, severe congestive heart failure (NYHA Class IV), unstable coronary artery disease]
- •5. History of epilepsy or seizures.
- •6. History of hypersensitivity to mammalian cell derived protein or any of the components of this product and human albumin.
- •7. History of malignancies.
- •8. History of anaemia due to other causes like acute or chronic blood loss, infections in last six weeks, iron deficiency anaemia (TSAT < 16%), Vitamin B12 or folic acid deficiency anaemia, untreated menorrhagia, hypothyroidism etc.
- •9. History of haemoglobinopathies.
- •10. Thrombocytopenia (platelet count <100,000/UL) or leukopenia (WBC < 2000/UL).
- •11. History of any other serious concurrent illness like systemic lupus erythematosus, Porphyria etc.
- •12. History of complications related with dialysis such as Osteitis fibrosa cystica, aluminum toxicity etc.
- •13. History of blood transfusion in past six weeks.
- •14. History of major surgery in last 12 weeks or planned surgery in next 6 weeks.
- •15. History of severe hepatic dysfunction.
- •16. Participation in any other trial in the past 3 months or concommitant participation in any other trial.
- •17. Not willing to give informed consent.
- •18. Patient, who according to the attending physician, is not able to understand and follow the instructions for follow-up.
研究者
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