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

Completed

• Conditions: Anemia, Kidney Disease, Chronic

• Registration Number: NCT01422824
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-02
• Results First Submitted: 2016-02-26
• Results First Submitted QC: 2016-02-26
• Last Update Submitted: 2016-02-26
• Results First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Levels	Baseline; Weeks 8, 16, 24, 48