An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

Study Overview
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Brief Summary
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This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Official Title
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An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

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: Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL) Participants had to be receiving an ESA prior to entering the study Female participants of childbearing age had to be using effective contraceptive methods Exclusion Criteria: As per approved package insert Any contraindication to ESA treatment

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 Renal Anemia Participants<br>Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months. | Drug: Methoxy polyethylene glycol epoetin beta<br> <br> * Other names: Mircera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) |  | Visit 2 (Month 1) | 
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2) |  | Visit 3 (Month 2) | 
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3) |  | Visit 4 (Month 3) | 
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4) |  | Visit 5 (Month 4) | 
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5) |  | Visit 6 (Month 5) | 
| Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6) |  | Visit 7 (Month 6) | 
| Mean Hemoglobin Value at Visit 2 (Month 1) |  | Visit 2 (Month 1) | 
| Mean Hemoglobin Value at Visit 3 (Month 2) |  | Visit 3 (Month 2) | 
| Mean Hemoglobin Value at Visit 4 (Month 3) |  | Visit 4 (Month 3) | 
| Mean Hemoglobin Value at Visit 5 (Month 4) |  | Visit 5 (Month 4) | 
| Mean Hemoglobin Value at Visit 6 (Month 5) |  | Visit 6 (Month 5) | 
| Mean Hemoglobin Value at Visit 7 (Month 6) |  | Visit 7 (Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study |  | Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6) | 
| Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta | Dose adjustment included dose increase or dose decrease with respect to previous visit's dose. | Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7) | 
| Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert | Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported. | Up to 6 months |