An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Hoffmann-La Roche185 enrolled

Overview

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

Study Type

OBSERVATIONAL

Enrollment

185

Conditions

Anemia, Kidney Disease, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Stage IV chronic kidney disease, on haemodialysis * Chronic renal anemia, on maintenance ESA treatment * Hemoglobin concentration between 10.0 an 12 g/dL * Continuous maintenance epoetin therapy with the same dosing interval during the previous month Exclusion Criteria: * Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension) * Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) * Anemia due to hemolysis, pure red cell aplasia

Locations (6)

Unnamed facility

Delcevo, North Macedonia

Unnamed facility

Prilep, North Macedonia

Unnamed facility

Shtip, North Macedonia

Unnamed facility

Skopje, North Macedonia

Unnamed facility

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.

Time frame: Up to 12 months

Secondary Outcomes

Hemoglobin Levels

Time frame: Baseline; Weeks 8, 16, 24, 48

Data from ClinicalTrials.gov

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