A clinical trial to assess the effect, safety and tolerability of MIRCERA administered intravenously or subcutaneously once in a month for the maintainance of Haemoglobin levels in dialysis patients with chronic renal anaemia
- Registration Number
- CTRI/2009/091/000455
- 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
- 170
? Written informed consent
? Age 18 years or older
? Chronic renal anaemia
? Haemoglobin concentration between 10.0 g/dl and 12.0 g/dL
? Adequate iron status as judged by Investigator
? Continuous intravenous or subcutaneous maintenance epoetin alfa therapy with the same dosing interval during the previous 2 months
? Regular long-term haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 2 months
? Blood transfusion during the previous 1 month
? Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication requiring hospitalization or interruption of epoetin alfa treatment in the previous 2 months
? Significant acute or chronic bleeding such as overt gastrointestinal bleeding
? Medically significant dialysis inadequacy
? Known malignant disease (except non-melanoma skin cancer)
? Known 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
? Known Folic acid deficiency (uncorrected in past 2 months)
? Known 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
? 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 the maintenance of haemoglobin levels, with once-monthly intravenous or subcutaneous administration of MIRCERA in dialysis patients with chronic renal anaemia.Timepoint: ?The proportion of patients maintaining mean haemoglobin concentration during last 4 weeks of Treatment Period (TP) within the target range i.e. 10.0 ? 12.0g/dL.
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of MIRCERA once monthly in the treatment of anaemia in dialysis patients with chronic kidney diseaseTimepoint: ? Change in mean haemoglobin concentration between reference (SVP) and in last 4 weeks of Treatment Period (TP)<br>? Mean time spent in haemoglobin range of 10.0 -12.0 g/d