An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Official Title
-----------------
Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA

Conditions
-----------------
Kidney Disease, Chronic

Intervention / Treatment
-----------------
* Drug: Methoxy polyethylene glycol-epoetin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged > 18 years with CKD Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC) Exclusion Criteria: Non-renal anemia Pregnancy and breast-feeding Uncontrolled hypertension Known hypersensitivity to methoxy polyethylene glycol-epoetin beta Administration of any other study drug within 30 days prior to study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD participants treated with Mircera<br>Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months. | Drug: Methoxy polyethylene glycol-epoetin beta<br> <br> * Other names: Mircera;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | Baseline | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 1-3 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 4-6 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 7-9 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 10-12 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 13-15 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 16-18 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 19-21 | 
| Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | After 21 Months up to 36 Months | 
| Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Baseline | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 1-3 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 4-6 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 7-9 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 10-12 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 13-15 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 16-18 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21 | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | At Months 19-21 | 
| Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months | If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation. | After 21 Months up to 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L |  | Up to 36 Months | 
| Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L |  | Up to 36 Months | 
| Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta | Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline | Baseline | 
| Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta | Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months. | Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months | 
| Number of Dose Adaptations | Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified). | Up to 36 Months | 
| Percentage of Participants With Dose 0 | Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period. | Up to 36 Months | 
| Percentage of Participants With Iron Replacement | Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both. | Up to 36 Months |