Subcutaneous Treatment of Anemia in patients with a GFR Below 45 ml/min/1.73m2 through Injections with Mircera as low frequent as Once monthly - STABILO

Active, not recruiting

• Conditions: Chronic renal anaemia; MedDRA version: 9.1Level: PTClassification code 10058116Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-005528-34-BE
• Lead Sponsor: .V. Roche S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

•Written informed consent
•Age 18 years or older
•Chronic renal anaemia defined as a GFR < 45 ml/min/1.73m2 (MDRD)
•Haemoglobin concentration = 9 and <11.0 g/dl
•Adequate iron status serum ferritin >100 ng/mL AND TSAT>20% (OR hypochromic red cells <10%)
•No ESA therapy during the previous 3 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 in the previous
6 months
•Significant acute or chronic bleeding such as overt gastrointestinal bleeding
•Active malignant disease (except non-melanoma skin cancer)
•History of primary bone marrow diseases
•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 the 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 except for
•cataract surgery
•vascular access surgery
•Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
•History of organ transplantation
•Life expectancy < 8 months

Study & Design

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