This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Unnamed facility
Adelaide, Australia
Unnamed facility
Gosford, Australia
Unnamed facility
Herston, Australia
Unnamed facility
Liverpool, Australia
Percentage of patients achieving target Hb within 20 weeks.
Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.
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Unnamed facility
Parkville, Australia
Unnamed facility
Perth, Australia
Unnamed facility
Sydney, Australia
Unnamed facility
Tasmania, Australia
Unnamed facility
Woolloongabba, Australia