A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease 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 monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Official Title
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A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis

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 kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis; continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month. Exclusion Criteria: transfusion of red blood cells during previous 2 months; significant acute or chronic bleeding; poorly controlled hypertension.

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 subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range. | Drug: Methoxy Polyethylene Glycol-epoetin Beta<br>* Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.<br>* Other names: C.E.R.A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period |  | Weeks 16-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Hb concentration |  | Between reference and Efficacy Evaluation Period | 
| Mean time spent in Hb range |  | Weeks 16-24 | 
| % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions |  | Weeks 16-48 | 
| AEs, lab parameters |  | Throughout study |