A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
|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|
|Actual Primary Completion Date :||December 2007|
|Actual 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422513
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|Study Director:||Clinical Trials||Hoffmann-La Roche|