OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

Study Overview
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Brief Summary
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This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

Official Title
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An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)

Conditions
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Anemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment) Life expectancy > 10 months Exclusion Criteria: Malignant disease Significant or acute bleeding Poorly controlled hypertension Blood transfusion during the previous 2 months Hypersensitivity to Mircera or any of its excipients

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with CKD<br>This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 | g/dL = grams per deciliter | Months 8 to 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | g/dL = grams per deciliter | Months 8 to 10 | 
| Percentage of Participants With MIRCERA Dose Adjustments | Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated. | Up to 10 months | 
| Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. | Up to 10 months |