Renal anemia in hemodialysis patients MedDRA version: 7.1 Classification code 10058116
Conditions
Interventions
Trade Name: NeoRecormon Multidose
Product Name: NeoRecormon Multidose
Product Code: RO2053859
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Epoetin beta
Conce
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of sc epoetin beta once weekly treatment to maintain stability of hemoglobin (Hb) in hemodialysis patients previously receiving intravenous (iv) darbepoetin alfa once weekly;Secondary Objective: - Hb level variability in Retrospective Phase, Adaptation Phase, and Evaluation Phase - Exploration of the conversion factor from darbepoetin to epoetin beta - Comparison of Hb variability in the 3 treatment groups - Comparison of Hb values under sc epoetin beta treatment in the Evaluation Phase (4 weeks) and Hb values from the Retrospective Phase under iv darbepoetin alfa treatment once weekly - Weekly dose of once weekly sc epoetin beta in Evaluation Phase - Weekly dose of iv darbepoetin alfa once weekly in Retrospective Phase - Safety and tolerability of epoetin beta in hemodialysis patients ;Primary end point(s): Main parameters of Efficacy - Proportion of patients with stable Hb values (change in target Hb by less than +/-1 g/dL) in Evaluation Phase (Weeks 21, 22, 23 and 24) with sc once weekly epoetin beta treatment - Mean weekly dose of sc epoetin beta once weekly to maintain stable Hb - Hb variability in Retrospective Phase, Adaptation Phase and Evaluation Phase - Hb values and dose of iv darbepoetin alfa once weekly in the Retrospective Phase Main parameters of safety - Adverse events (serious and non-serious) - Clinical laboratory tests and vital signs | — |
Countries
Italy, Sweden
Outcome results
None listed