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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

393 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Disease, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CKD participants treated with Mircera

Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.

Methoxy polyethylene glycol-epoetin beta

Intervention Type DRUG

Interventions

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Methoxy polyethylene glycol-epoetin beta

Intervention Type DRUG

Other Intervention Names

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Mircera

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No