An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice

NCT ID: NCT01690455

Last Updated: 2016-11-02

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

247 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-06-30

Brief Summary

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This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/=18 years of age
* Adequate iron status
* Signed informed consent form

Exclusion Criteria

* Anemia due to non-renal causes
* Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
* Pregnant or lactating female patients
* Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
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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Bartoszyce, , Poland

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Bydgoszcz, , Poland

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Ciechanów, , Poland

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Częstochowa, , Poland

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Dębica, , Poland

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Gliwice, , Poland

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Gmina Świecie, , Poland

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Gorzów Wielkopolski, , Poland

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Grudziądz, , Poland

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Hajnówka, , Poland

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Jastrzębie Zdrój, , Poland

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Jaworzno, , Poland

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Kępno, , Poland

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Konin, , Poland

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Kościerzyna, , Poland

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Lodz, , Poland

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Milicz, , Poland

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Piła, , Poland

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Polanica-Zdrój, , Poland

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Radom, , Poland

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Rybnik, , Poland

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Rzeszów, , Poland

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Rzeszów, , Poland

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Sandomierz, , Poland

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Siedlce, , Poland

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Starachowice, , Poland

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Suwałki, , Poland

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Słupsk, , Poland

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Warsaw, , Poland

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Wołomin, , Poland

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Wroclaw, , Poland

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Zgorzelec, , Poland

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Łapy, , Poland

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Countries

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Poland

Other Identifiers

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ML25701

Identifier Type: -

Identifier Source: org_study_id