A Clinical Trial to assess the effect, safety and tolerability of MIRCERA administered intravenously two weekly for treating the chronic renal anaemia in dialysis patients who are not receiving ESA treatment currently
- Registration Number
- CTRI/2009/091/000452
- Lead Sponsor
- Roche Products India Pvt Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
? 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
? 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
3 months
? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
? Planned (date) elective surgery during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess effectiveness of two-weekly intravenous administration of MIRCERA in dialysis patients with chronic renal anaemia, not currently treated with ESA.Timepoint: ? Mean change in Hb concentration from baseline (week 0) and last visit (week 16) of the TP
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of MIRCERA two weekly dosing in the treatment of anaemia in patients with chronic kidney disease.Timepoint: ? Time to achievement of response (achievement of Hb levels within target range i.e. 10.0 ? 12.0 g/dL)<br>? The percentage of patients whose average Hb concentration is within the range 10.0 ? 12.0 g/dL in the last 4 weeks of TP<br>? Mean time spent in Hb range of 10.0 ? 12.0 g/dL during the last 4 weeks of TP<br>