Health Condition 1: null- Anemia due to Chronic Kidney Disease
Conditions
Interventions
Intervention1: Peg EPO: 0.6 microgram/kg body weight, once every 2 weekly as subcutaneous Injection up to10 weeks
Control Intervention1: MIRCERA®: 0.6 microgram/kg body weight, once every 2 weekly as
Sponsors
Intas Biopharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex with an age >= 18 years 2.Anemia 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare proportion of patients achieving a pre-specified Hb targetTimepoint: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare mean dose of Intas Peg EPO with MIRCERA® required to achieve target HbTimepoint: 84 Days;To observe & compare Incidence of drug related Adverse Events as assessed by clinical examination, vitals and / or laboratory parametersTimepoint: 84 Days | — |
Countries
India
Contacts
Public ContactDr Naman Shah
Intas Biopharmaceuticals Limited
Outcome results
None listed