E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Renal anemia in hemodialysis patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Classification code | 10058116 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
− 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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends when 700 patients are randomized and treated for the whole trial period of 6 months (i.e. last visit of the last subject).
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |