An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

Study Overview
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Brief Summary
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This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Official Title
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The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

Conditions
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Kidney Disease, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults patients, >/=18 years of age Presence of chronic kidney disease (Stage 3-4) Exclusion Criteria: Participation in another clinical study

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<br>Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Dose of MIRCERA at Entry Level | The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported. | Baseline | 
| Average Dose of MIRCERA During Titration Period Month 1 | The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported. | Month 1 | 
| Average Dose of MIRCERA During Titration Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 2 | 
| Average Dose of MIRCERA During Titration Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 3 | 
| Average Dose of MIRCERA During Titration Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported. | Month 4 | 
| Average Dose of MIRCERA During Maintenance Period Month 1 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 5 (Maintenance Period Month 1) | 
| Average Dose of MIRCERA During Maintenance Period Month 2 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 6 (Maintenance Period Month 2) | 
| Average Dose of MIRCERA During Maintenance Period Month 3 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 7 (Maintenance Period Month 3) | 
| Average Dose of MIRCERA During Maintenance Period Month 4 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 8 (Maintenance Period Month 4) | 
| Average Dose of MIRCERA During Maintenance Period Month 5 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 9 (Maintenance Period Month 5) | 
| Average Dose of MIRCERA During Maintenance Period Month 6 | The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported. | Month 10 (Maintenance Period Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Hemoglobin (Hb) Level During Titration Period | The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA. | Baseline, Month 1, 2, 3, 4 | 
| The Mean Hemoglobin (Hb) Level During Maintenance Period | The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA | Month 5, 6, 7, 8, 9, 10 |