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Observational Study of MIRCERA in Users of Self-Application and Multidose Systems

NCT ID: NCT02540213

Last Updated: 2015-12-22

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

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

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This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.

Detailed Description

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Conditions

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Renal Anemia of Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MIRCERA Ready-To-Use-Syringe

Participants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram \[mcg/kg\]) every 2 weeks (q2w) up to 9 months

MIRCERA

Intervention Type DEVICE

Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.

Interventions

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MIRCERA

Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Anemia caused by CKD only
* Life expectancy of more than (\>) 9 months in the judgment of the attending physician
* Ferritin \>200 micrograms per liter (mcg/L) in accordance with the relevant guidelines
* The time point of changing to Mircera was only 3 months ago at the longest

Exclusion Criteria

N/A
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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Daun, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML21387

Identifier Type: -

Identifier Source: org_study_id