A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

NCT ID: NCT01356589

Last Updated: 2017-07-05

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

1288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-07-31

Brief Summary

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This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.

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

RETROSPECTIVE

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 predialysis (stage 3 and 4) and dialysis
* Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent

Exclusion Criteria

* Participation in an interventional clinical trial within the retrospective observation period
* Contraindications to Mircera administration as per label or judged by the investigator
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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Timios Stavros Clinic; Nephrology Department

Aigáleo, , Greece

Site Status

General Hospital of Artas; Nephrology

Arta, , Greece

Site Status

Attikon Center; Nephrology

Athens, , Greece

Site Status

Athinaiki Private Clinic

Athens, , Greece

Site Status

Hospital henry dunant; Nephrology

Athens, , Greece

Site Status

General Hospital Hippokration of Athens; Nephrology

Athens, , Greece

Site Status

General Hospital Of Athens G.Gennimatas; Nephrology

Athens, , Greece

Site Status

Kyanos Stavros Private Hospital; Nephrologic Clinic

Athens, , Greece

Site Status

General Hospital Of West Attikis; Nephrology

Athens, , Greece

Site Status

University Hospital Attikon ; Pathology Clinic

Athens, , Greece

Site Status

General Hospital Agia Olga; Nephrology

Athens, , Greece

Site Status

Iaso General Private Clinic; Nephrology

Athens, , Greece

Site Status

Iatriko Athinon Clinic Dafnis; Nephrology Department

Daphni-athens, , Greece

Site Status

General Hospital Of Dramas; Dialysis Center Unit

Drama, , Greece

Site Status

University Hospital Of Heraklion; Nefrologiki Clinic

Heraklion, , Greece

Site Status

General Hospital Of Katerinis; Nephrology Unit

Katerini, , Greece

Site Status

General Hospital Of Lamias; Nephrology

Lamia, , Greece

Site Status

Univeristy Hospital of Larissa; Nephrology

Larissa, , Greece

Site Status

Eytychios Patsidis Center Of Haemodialysis

Larissa, , Greece

Site Status

General Hospital Of Leykadas; Dialysis Center Unit

Leykada, , Greece

Site Status

Leivadia General Hospital; Nephrologic Clinic

Livadeia, , Greece

Site Status

Kyanous Stavros of Patras, Renal Disease Therapy Unit

Pátrai, , Greece

Site Status

Olympion Therapeytirion; Nefrology

Pátrai, , Greece

Site Status

General Hospital Tzanio ; Nephrology

Piraeus, , Greece

Site Status

General Hospital Of Chalkidikis; Dialysis Center Unit

Polygyros, , Greece

Site Status

Rodos General Hospital; Nephrologic Clinic

Rhodes, , Greece

Site Status

Alpha Nephrodynamiki Of Serres; Dialysis Center Unit

Serres, , Greece

Site Status

Ahepa Hospital; 1St Dept. of Medicine

Thessaloniki, , Greece

Site Status

IPPOKRATES Private Dialysis Centre

Thessaloniki, , Greece

Site Status

General Hospital Of Thessalonikis Papageorgiou; Nephrology

Thessaloniki, , Greece

Site Status

Alfa Nefrodynamiki; Nefrology

Thessaloniki, , Greece

Site Status

Thessaliki Nossileytiki; Nephrology

Volos, , Greece

Site Status

General Hospital of Volos; Nephrology

Volos, , Greece

Site Status

Countries

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Greece

Other Identifiers

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ML25289

Identifier Type: -

Identifier Source: org_study_id

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