An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant

Study Overview
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Brief Summary
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This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.

Official Title
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Non-interventional, Observational Study to Investigate the Efficiency and Safety of Mircera in Patients With a Kidney Transplant

Conditions
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Anemia, Kidney Transplantation

Intervention / Treatment
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* Drug: Methoxy-polyethyleneglycol epoetin beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor. The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis. Exclusion Criteria: Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (>/=) 2 g/dL between two sequential values. Administration of other ESA therapies during the observation period.

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 |
| --- | --- |
| Kidney Transplant Participants<br>Participants with kidney transplant and a chronic kidney disease who were receiving methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care. | Drug: Methoxy-polyethyleneglycol 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 |
| --- | --- | --- |
| Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) |  | From Month 7 to Month 9 | 
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) |  | From Month 7 to Month 9 | 
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) |  | From Month 7 to Month 12 | 
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) |  | From Month 7 to Month 15 | 
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) |  | From Month 7 to Month 12 | 
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) |  | From Month 7 to Month 15 | 
| Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment |  | Up to 50 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | 
| Hemoglobin Level Based on the Presence of Inflammatory Diseases | Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | 
| Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | 
| Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | 
| Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented. | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) |