A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

Study Overview
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Brief Summary
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This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Official Title
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Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)

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: Adult participants, >=18 years of age; Chronic renal anemia; No ESA therapy during previous 3 months. Exclusion Criteria: Transfusion of red blood cells during previous 2 months; Poorly controlled hypertension requiring hospitalization in previous 6 months; Significant acute or chronic bleeding.

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 received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period. | Drug: methoxy polyethylene glycol-epoetin beta<br>* 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)<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 Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range | The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL. | Weeks 29-36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP) | The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP. | Weeks 0-36 | 
| Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP) |  | Weeks 29-36 | 
| Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) |  | Weeks 29-36 | 
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Weeks 1-40 |