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: Chronic renal anemia; MedDRA version: 8.1Level: PTClassification code 10058116Term: Nephrogenic anaemia

• Registration Number: EUCTR2006-006523-40-SE
• Lead Sponsor: Roche AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified