A Prospective, Comparative, Randomized, Multicenter Study of Peg EPO in the Treatment of Anemia due to Chronic Kidney Disease

Intas Biopharmaceuticals Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients of either sex with an age >= 18 years
•3.Have not participated in any other investigational drug trial in the last 3 months
•4.Have given informed consent to participate in this study

•1.Patient who have overt gastrointestinal bleeding,or bleeding episode necessitating transfusion within 4 weeks before screening.
•2.Patient who have any active malignant disease (except non-melanoma skin cancer).
•3.Patients with known hypersensitivity to mammalian cell-derived products or Albumin (Human)
•4.Patients with uncontrolled hypertension.
•5.Patients scheduled for major elective orthopaedic surgery or renal transplant and not participating in an autologous blood predonation
•programme, patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident or any serious life threatening disease or disorder.
•6.Any history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator could jeopardize the safety of the subject or the validity of the study results
•7.Patient with any specific disease who are not eligible for the use of erythropoiesis stimulating agent (ESA).
•8.Hypersensitivity to the active substance or to any of the excipients
•9.Patients who for any reason cannot receive adequate antithrombotic prophylaxis
•10.Pregnant and / or Breast feeding Female Patient

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