Effectiveness of a once weekly subcutaneous epoetin beta treatment in hemodialysis patients. - Alfa2Beta

• Conditions: Renal anemia in hemodialysis patients; MedDRA version: 7.1Classification code 10058116

• Registration Number: EUCTR2004-000983-29-SE
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

- Informed consent
- Stable hemodialysis patients with renal anemia treated with iv darbepoetin alfa once weekly for at least 12 weeks prior to study enrollment
- Stable Hb-values (11 – 13 g/dL, determined before hemodialysis) in the last 12 weeks prior to enrollment
- Sample for anti erythropoietin-antibody test taken at baseline
- Sample for Vit B12 and folic acid assessment taken at baseline
- Absolute reticulocyte number >10.000 cells/µL in the last 12 weeks before enrolment and no evidence of loss of efficacy under darbepoetin alfa treatment in patient history
- Kt/V = 1.2
- Patients >18 years old

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

- Anti-erythropoietin-antibodies in serum/or and evidence of loss of efficacy under darbepoetin alfa or epoetin alfa treatment in patient history suggesting presence and/or signs of pure red cell aplasia (PCRA)
- Severe concomitant chronic disease (e.g., chronic heart failure, New York Heart Association [NYHA] III and IV) or active malignant disease
- Life expectancy <2 year
- Serum ferritin <100 ng/mL and/or transferrin saturation (TSAT) <20%
- Pregnancy or breast feeding

Study & Design

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