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 dialysis patients with chronic renal anaemia - MORECERA
- Conditions
- To assess the long term maintenance of haemoglobin levels, with once-monthly intravenous administration of C.E.R.A. in dialysis patients with chronic renal anaemia.MedDRA version: 9.1Level: LLTClassification code 10058132Term: Renal anemia
- Registration Number
- EUCTR2006-005621-28-HU
- Lead Sponsor
- Roche (Hungary) Ltd
- 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 therapy with the same dosing interval during the previous month during the previous month and no change in total ( calculated) weekly dose
•Regular long-term haemodialysis dialysis 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: haptoglobin <30 mg/dl (3.54 micromol/L) or other reliable positive test of haemolysis
•Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types)
•Folic acid deficiency, uncorrected in past 2 months as measured by local lab values, e.g. erythrocyte MCV 105 fL
•Vitamin B12 deficiency, uncorrected in past 2 months as measured by local lab values, e.g. erythrocyte MCV 105 fL
•Platelet count >500 giga/L or <100 giga/L
•Pure red call 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 at investigator’s discretion, during the previous 3 months
•Uncontrolled or symptomatic secondary hyperparathyroidism, at investigator’s discretion
•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 and 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 dialysis patients with chronic renal anaemia.;Secondary Objective: 1. To evaluate the safety and tolerability of C.E.R.A. once monthly in the treatment of anaemia in patients with chronic kidney disease.<br>2. To explore associations between NT-proBNP levels and clinical outcomes observed during the study. ;Primary end point(s): Primary efficacy endpoint: <br>•The proportion of patients maintaining average haemoglobin concentration during the Efficacy Evaluation Period within the target range. <br>
- Secondary Outcome Measures
Name Time Method