A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

Study Overview
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Brief Summary
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An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.

Conditions
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Anemia

Intervention / Treatment
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* Other: MIRCERA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants above 18 years of age Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated) Exclusion Criteria: Participants involved in interventional trials Participants with life expectancy less than 1 year Active malignancy Planned living kidney transplant within 6 months.

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 |
| --- | --- |
| Cohort of CKD Participants<br>Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months. | Other: MIRCERA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion |  | Pre-baseline (Month -6) | 
| Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion |  | Pre-baseline (Month -3) | 
| Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline |  | Baseline | 
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion |  | Month 3 | 
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion |  | Month 6 | 
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion |  | Month 9 | 
| Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion |  | Month 12 | 
| Mean Hb Value at Month 6 Before Inclusion |  | Pre-baseline (Month -6) | 
| Mean Hb Value at Month 3 Before Inclusion |  | Pre-baseline (Month -3) | 
| Mean Hb Value at Baseline |  | Baseline | 
| Mean Hb Value at Month 3 After Inclusion |  | Month 3 | 
| Mean Hb Value at Month 6 After Inclusion |  | Month 6 | 
| Mean Hb Value at Month 9 After Inclusion |  | Month 9 | 
| Mean Hb Value at Month 12 After Inclusion |  | Month 12 | 
| Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | Pre-baseline (Month -6) to Baseline | 
| Percentage of Participants With Hb Fluctuation From Baseline to Month 12 | Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits. | Baseline to Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Change in MIRCERA Treatment | Change in MIRCERA treatment included changes in dose, frequency, and route of administration. | Months 3, 6, 9, and 12 | 
| Percentage of Participants With Number of MIRCERA Dose Changes |  | Baseline to Month 12 | 
| Correlation of Hb Levels With Underlying Disease |  | Baseline to 12 months | 
| Correlation of Hb Levels With Levels of Inflammation |  | Baseline to 12 months | 
| Percentage of Participants With Changes in Iron Supplement | Percentage of participants who had any change in their iron supplement medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 | 
| Percentage of Participants With Changes in Immunosuppressive Treatment | Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 | 
| Percentage of Participants With Changes in AntihypertensiveTreatment | Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported. | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 | 
| Number of Participants With Different Medication Treatment | Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category. | Pre-baseline (Month -6) to Month 12 | 
| Percentage of Participants Who Required Blood Transfusion |  | Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12 | 
| Percentage of Participants Who Required Renal Replacement Therapy | Renal replacement therapy was defined as hemodialysis and peritoneal dialysis. | Months 3, 6, 9, and 12 |