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An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

NCT ID: NCT01051323

Last Updated: 2015-12-18

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

1580 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-02-28

Brief Summary

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This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.

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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1

methoxy polyethylene glycol-ep [Mircera]

Intervention Type DRUG

As prescribed by physician

Interventions

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methoxy polyethylene glycol-ep [Mircera]

As prescribed by physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/= 18 years of age
* chronic kidney disease
* informed consent for data transmission

Exclusion Criteria

* serious hematological or infectious disease
* acute bleeding in the 16 weeks preceding data collection
* participation in an interventional trial
* female patients: pregnancy or breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

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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Saarlouis, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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ML22714

Identifier Type: -

Identifier Source: org_study_id