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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-000983-29-SE |
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Date of registration:
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26/10/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of a once weekly subcutaneous epoetin beta treatment in hemodialysis patients. - Alfa2Beta
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Scientific title:
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Effectiveness of a once weekly subcutaneous epoetin beta treatment in hemodialysis patients. - Alfa2Beta |
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Date of first enrolment:
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12/01/2005 |
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Target sample size:
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700 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000983-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Sweden
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Renal anemia in hemodialysis patients
MedDRA version: 7.1
Classification code 10058116
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Intervention(s)
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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
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 100,000-
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Primary Outcome(s)
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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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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
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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
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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