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
NA
31 participants
INTERVENTIONAL
2010-02-28
2012-04-30
Brief Summary
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Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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C.E.R.A.
C.E.R.A. every 4 and then every 2 weeks
comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
Darbepoetin
Darbepoetin alfa every 4 and then every 2 weeks
comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
Interventions
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comparison between darbepoetin alfa and C.E.R.A. and different administration intervals
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Ospedale Regionale di Locarno
OTHER
Responsible Party
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Luca Gabutti, MD
Head of Department; internal medicine
Principal Investigators
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Luca Gabutti, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Regionale Locarno
Locations
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Ospedale Regionale Locarno
Locarno, Canton Ticino, Switzerland
Countries
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References
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Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, Gabutti L. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol. 2013 Jul 22;14:157. doi: 10.1186/1471-2369-14-157.
Other Identifiers
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Epo-Loc1
Identifier Type: -
Identifier Source: org_study_id