A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

Study Overview
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Brief Summary
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This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. 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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An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia.

Conditions
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Anemia

Intervention / Treatment
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* Drug: epoetin beta
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female patients, >=18 years of age; chronic renal anemia; Hb concentration 10.0 - 12.0 g/dL during the screening period; continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening. Exclusion Criteria: blood transfusion within the previous 8 weeks; poorly controlled hypertension; significant or acute or chronic bleeding; active malignant disease; congestive heart failure (NYHA Class IV).

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: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 120, 200 or 360 micrograms every 4 weeks<br>|
| Active Comparator: 2<br> | Drug: epoetin beta<br>* As prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin concentration between baseline and the EEP |  | Week 20-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP. |  | Weeks 1-28 | 
| Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP. |  | Weeks 1-28 | 
| Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG. |  | Throughout study |