A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia

Study Overview
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Brief Summary
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This single arm study will assess the long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialysis participants with chronic renal anemia. Participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in Week -1. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dL).

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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Methoxy Polyethylene Glycol-Epoetin Beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic renal anemia; Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month; Hb concentration between 10 and 12 g/dL; Adequate iron status. Exclusion Criteria: Transfusion of red blood cells during previous 2 months; Significant acute or chronic bleeding, such as overt gastrointestinal bleeding; Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months; Active malignant disease.

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>Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks. | Drug: Methoxy Polyethylene Glycol-Epoetin Beta<br>* 120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.<br>* Other names: CERA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP) | The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration). | EEP: Weeks 17 to 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb Concentrations Between EEP and Stability Verification Period (SVP) | Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated. | SVP: Week -4 to Week 0; EEP: Weeks 17 to 28 | 
| Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP |  | EEP: Weeks 17 to 28 | 
| Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP |  | EEP: Weeks 17 to 28 | 
| Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP | The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted. | DTP: Weeks 1 to 16; EEP: Weeks 17 to 28 | 
| Percentage of Participants Who Required Red Blood Cell Transfusions |  | Weeks 1 to 28 |