Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2002-09-01
2006-07-31
Brief Summary
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Detailed Description
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Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase \>1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb \> 10.5 g/dL was achieved.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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iron therapy with good response
Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb \> 10.5 g/dL was achieved.
iron sucrose (200 mg VENOFER®)
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
iron therapy with poor response
Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase \<0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).
iron sucrose (200 mg VENOFER®)
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
recombinant human erythropoietin (10,000 U EPREX®)
According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
iron therapy and erythropoietin
Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.
iron sucrose (200 mg VENOFER®)
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
recombinant human erythropoietin (10,000 U EPREX®)
According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
Interventions
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iron sucrose (200 mg VENOFER®)
According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
recombinant human erythropoietin (10,000 U EPREX®)
According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* folic acid deficiency anemia
* hemoglobinopathy
* multiples
* liver disease
* kidney disease
FEMALE
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Roland Zimmermann, Prof.
Role: STUDY_DIRECTOR
University of Zurich
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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34130203
Identifier Type: -
Identifier Source: org_study_id