A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Study Overview
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Brief Summary
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This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
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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.

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta
* Drug: Epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; CKD (stage V) on outpatient hemodialysis therapy for >= 3 months; CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months; average hemoglobin (Hb) 10-12 g/dL over last 3 months. Exclusion Criteria: failed renal transplant within 12 months prior to screening; poorly controlled hypertension; previous treatment with Mircera.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methoxy polyethylene glycol-epoetin beta<br>120-360 micrograms (iv) monthly, starting dose | Drug: methoxy polyethylene glycol-epoetin beta<br>* 120-360 micrograms intravenous (iv) monthly, starting dose<br>* Other names: Mircera;|
| Active Comparator: Epoetin Alfa<br>As prescribed, (iv), 3 times weekly | Drug: Epoetin alfa<br>* As prescribed, iv, 3 times weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Spent on Anemia Treatment Over Evaluation Period | Efficacy and pharmacoeconomics analyses were not performed. | Months 5-7 | 
| Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period | Efficacy and pharmacoeconomics analyses were not performed. | Baseline, Months 5-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Assessed for AEs | The adverse events are captured in the adverse event and serious adverse event section of this database. | Month 1 to 15 day follow up post month 7 | 
| The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants | 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. | Baseline, Month 1 to Month 7 |