A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous C.E.R.A. for the maintenance of haemoglobin levels in haemodialysis patients with chronic renal anaemia. - CARISMA
- Conditions
- Chronic renal anemia.MedDRA version: 9.1Level: LLTClassification code 10039812Term: Secondary anaemia
- Registration Number
- EUCTR2007-005799-15-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%) Continuous intravenous maintenance epoetin alfa or beta or darbepoetin alfa therapy with the same dosing interval during the previous month and no change in total (calculated) weekly dose Regular long-term haemodialysis therapy with the same mode of dialysis for at least the previous 3 months Kt/V > 1.0 at screening for haemodialysis patients (or URR >55%)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Transfusion of red blood cells during the previous 2 months Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mmHg 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) Haemolysis Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types) Folic acid deficiency Vitamin B12 deficiency Platelet count >500 x 109/L or <100 x 109/L Pure red cell aplasia 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 Uncontrolled or symptomatic secondary hyperparathyroidism 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 except for - cataract surgery - temporary (untunneled) dialysis access catheter
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long term maintenance of haemoglobin levels, with once-monthly intravenous administration of C.E.R.A. in haemodialysis patients with chronic renal anaemia.;Secondary Objective: To evaluate the safety and tolerability of C.E.R.A. once monthly in the treatment of anaemia in patients with chronic kidney disease.;Primary end point(s): The proportion of patients maintaining average haemoglobin concentration during the EEP within the target range.
- Secondary Outcome Measures
Name Time Method