A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

Study Overview
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Brief Summary
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This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Official Title
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A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

Conditions
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Anemia

Intervention / Treatment
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* Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic renal anemia; Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month; Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months. Exclusion Criteria: Transfusion of red blood cells during previous 2 months; Significant acute or chronic bleeding, such as overt gastrointestinal bleeding; Active malignant disease (except non-melanoma skin cancer).

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C.E.R.A.<br> | Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)<br>* Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.<br>* Other names: Mircera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range | Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average. | Week 17 up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Concentration Between Reference SVP and EEP | The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed. | Week -4 up to Week 0 and Week 17 up to Week 24 | 
| Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range | Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed. | Week 17 up to Week 24 | 
| Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP | Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed. | Week 17 up to Week 24 | 
| Percentage of Participants Requiring Any Dose Adjustment | Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported. | Week 1 up to Week 16 and Week 17 up to Week 24 | 
| Number of Participants With Red Blood Cell Transfusion During the Study | Number of participant who underwent red blood cell transfusion during the study was reported. | Week -4 up to Week 52 |