A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
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|ClinicalTrials.gov Identifier: NCT00422513|
Recruitment Status : Terminated (Strategic decision unrelated to safety or efficacy)
First Posted : January 17, 2007
Results First Posted : December 14, 2011
Last Update Posted : December 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: methoxy polyethylene glycol-epoetin beta Drug: Epoetin alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.|
|Study Start Date :||March 2007|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
Experimental: methoxy polyethylene glycol-epoetin beta
120-360 micrograms (iv) monthly, starting dose
Drug: methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
Other Name: Mircera
Active Comparator: Epoetin Alfa
As prescribed, (iv), 3 times weekly
Drug: Epoetin alfa
As prescribed, iv, 3 times weekly
- Time Spent on Anemia Treatment Over Evaluation Period [ Time Frame: Months 5-7 ]Efficacy and pharmacoeconomics analyses were not performed.
- Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period [ Time Frame: Baseline, Months 5-7 ]Efficacy and pharmacoeconomics analyses were not performed.
- Number of Participants Assessed for AEs [ Time Frame: Month 1 to 15 day follow up post month 7 ]The adverse events are captured in the adverse event and serious adverse event section of this database.
- The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants [ Time Frame: Baseline, Month 1 to Month 7 ]A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422513
Show 44 Study Locations
|Study Director:||Clinical Trials||Hoffmann-La Roche|