A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

Study Overview
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Brief Summary
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This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

Official Title
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A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®

Conditions
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Renal Anemia of Chronic Kidney Disease

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: Participants with chronic kidney disease not on dialysis Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study Hemoglobin level less then (<)10 grams per deciliter (g/dL) at inclusion Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start Exclusion Criteria: Functional renal transplant Current participation in a clinical trial in anemia due to chronic kidney 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Kidney Disease Participants<br>Participants for whom the treating physician has decided to initiate treatment with MIRCERA for medical reasons prior to study start, will be observed for 9 months. | Drug: Methoxy Polyethylene Glycol-Epoetin Beta<br>* Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.<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 With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse |  | Baseline, Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels According to Liu Index and Resistance Factors |  | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 | 
| Average Dose of Mircera in Total Population |  | Baseline up to 9 months | 
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population |  | Baseline up to 9 months | 
| Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation |  | Baseline up to 9 months | 
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation |  | Baseline up to 9 months | 
| Duration of Treatment With Mircera |  | Baseline up to 9 months | 
| Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia |  | Baseline up to 9 month |