CTRI/2009/091/000452CompletedPhase 4
A single arm open label study to assess the efficacy, safety and tolerability of two weekly administration of intravenous MIRCERA for the treatment of chronic renal anaemia in dialysis patients not currently treated with ESA
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 220
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •? Written informed consent
- •? Age 18 years or older
- •? Chronic renal anaemia
- •? Haemoglobin concentration between 8 g/dL and 10 g/dL
- •? No prior ESA therapy during the previous 2 months
- •? Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
- •? Haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 4 Weeks
Exclusion Criteria
- •? Blood transfusion during the previous 4 Weeks
- •? Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication. Average of 2 values measured at least two hours apart before dialysis
- •? Significant acute or chronic bleeding such as overt gastrointestinal bleeding
- •? Active malignant disease (except non-melanoma skin cancer)
- •? History of Haemolysis
- •? History of Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •? Platelet count >500 x 109/L or <100 x 109/L
- •? History of Pure red cell aplasia
- •? Folic acid deficiency, uncorrected in past 2 months
- •? Vitamin B12 deficiency, uncorrected in past 2 months
- •? Epileptic seizure during previous 6 months
- •? Congestive heart failure (NYHA Class IV)
- •? Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
- •? Pregnancy or lactation period
- •? Women of childbearing potential without effective contraception
- •? Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous
- •? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •? Planned (date) elective surgery during the study period
Investigators
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