An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis

Study Overview
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Brief Summary
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This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

Official Title
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Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Methoxy Polyethylene Glycol-Epoetin Beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD participants undergoing dialysis Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%) Exclusion Criteria: Conditions known to cause inadequate response to ESA treatment Anemia other than symptomatic anemia associated with CKD

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 |
| --- | --- |
| Methoxy Polyethylene Glycol-Epoetin Beta<br>Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period. | Drug: Methoxy Polyethylene Glycol-Epoetin Beta<br>* Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.<br>* Other names: Mircera®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Day 1 | 
| Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg). | Month 6 | 
| Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 |  | Baseline, Month 6 | 
| Serum CRP Level |  | Baseline, Month 6 | 
| Serum IL-6 Level |  | Baseline, Month 6 | 
| Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Month 6 | 
| Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 | Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r). | Month 6 | 
| Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose |  | Day 1 | 
| Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose |  | Day 1 | 
| Serum Hemoglobin Level |  | Baseline, Month 6 |