EUCTR2006-006523-40-SEActive, not recruitingNot Applicable
A single arm open label study to assess the efficacy, safety and tolerability and of once-monthly administration of subcutaneous C.E.R.A. for the maintenance of haemoglobin levels in pre-dialysis patients with chronic renal anaemia. - Umbrella
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Roche AB
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Written informed consent
- •- Age 18 years or older
- •- Chronic renal anaemia
- •- Haemoglobin concentration between 10.5 g/dl and 12.5 g/dl
- •- Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
- •- Continuous subcutaneous maintenance darbepoetin alfa therapy with the same dosing interval during the previous 2 months
- •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
Exclusion Criteria
- •- Transfusion of red blood cells during the previous 2 months
- •- Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of darbepoetin alfa treatment in the previous 6 months
- •- 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
- •- Planned (date) elective surgery during the study period except for
- •- cataract surgery
- •- vascular access surgery
- •- Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Investigators
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