An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-11-30

Brief Summary

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This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

Detailed Description

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Conditions

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Anemia, Kidney Disease, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Chronic kidney disease, in pre-dialysis or dialysis
* Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria

* Anemia due to non-renal causes
* Pregnant or lactating women
* Uncontrolled hypertension
* Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Tirana, , Albania

Site Status

Countries

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Albania

Other Identifiers

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ML25465

Identifier Type: -

Identifier Source: org_study_id