An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

Study Overview
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Brief Summary
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This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.

Official Title
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Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-ep [Mircera]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >/= 18 years of age chronic kidney disease informed consent for data transmission Exclusion Criteria: serious hematological or infectious disease acute bleeding in the 16 weeks preceding data collection participation in an interventional trial female patients: pregnancy or breast-feeding

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 |
| --- | --- |
| 1<br> | Drug: methoxy polyethylene glycol-ep [Mircera]<br>* As prescribed by physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented. | Month 0 to Month 12 | 
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented. | Month 0 to Month 12 | 
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size | The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented. | Month 6 to Month 12 | 
| Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants. | Month 0 to Month 12 | 
| Serum Ferritin Values | Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | 
| Serum Iron Values | Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | 
| Transferrin Values | Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | 
| Transferrin Saturation Values | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | 
| C-reactive Protein (CRP) Values | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | 
| Number of Physicians Satisfied With Treatment at Final Visit | Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were very satisfied, satisfied, undecided, or not satisfied. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation | 
| Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion | At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation | 
| Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion | At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation | 
| Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy | Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation | 
| Number of Participants Satisfied With Treatment at Final Visit | Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were very satisfied, satisfied, undecided, or not satisfied. Data for this outcome measure was reported for overall participants. | Month 12 or early discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants. | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 |