A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

Study Overview
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Brief Summary
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This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Official Title
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A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

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 Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks Exclusion Criteria: Transfusion of red blood cells during previous 8 weeks Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months Acute or chronic bleeding requiring therapy within previous 8 weeks

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: methoxy polyethylene glycol-epoetin beta<br> | Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]<br>* Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP) | The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24. | EEP (Weeks 16 to 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hb Concentration Between SVP and the EEP | The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24. | SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24) | 
| Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP | The EEP was defined as Week 16 to Week 24. | EEP (Weeks 16 to 24) | 
| Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP | The EEP was defined as Week 16 to Week 24. | EEP (Weeks 16 to 24) | 
| Percentage of Participants With Blood Transfusion |  | Baseline up to Week 28 | 
| Percentage of Participants With Dose Adjustment | A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline. | Baseline up to Week 20 |