An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-03-31

Brief Summary

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This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

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Detailed Description

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Conditions

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Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Mircera

Intervention Type DRUG

Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Interventions

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Mircera

Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, age 18 years or above
* Chronic kidney disease (CKD) with anemia
* Patients on dialysis receiving short-acting epoetin (EPO)
* Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%

Exclusion Criteria

* Patients unwilling to give informed consent
* Uncontrolled hypertension
* Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
* Relevant acute or chronic bleeding history
* Hemolysis
* Hemoglobinopathies
* Pure red cell aplasia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No