A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
NCT ID: NCT02569515
Last Updated: 2016-11-02
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
58 participants
INTERVENTIONAL
2004-10-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epoetin Beta
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
Epoetin Beta
Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
Interventions
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Epoetin Beta
Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic renal failure (Stages I-III)
* No previous epoetin therapy
Exclusion Criteria
* History or evidence of malignancy
* Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
* Women who are pregnant or breastfeeding
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Countries
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Other Identifiers
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ML18101
Identifier Type: -
Identifier Source: org_study_id