Peg EPO in the Treatment of Anemia due to Chronic Kidney Disease
- Conditions
- Health Condition 1: null- Anemia due to Chronic Kidney Disease
- Registration Number
- CTRI/2013/09/003956
- Lead Sponsor
- Intas Biopharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare proportion of patients achieving a pre-specified Hb targetTimepoint: End of study
- Secondary Outcome Measures
Name Time Method 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