An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

NCT ID: NCT01974271

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

661 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.

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
* Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
* Previously treated with an erythropoietin stimulating agent (ESA)
* Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
* Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL

Exclusion Criteria

* Current participation in a clinical trial on renal anemia
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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Aix-en-Provence, , France

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Ajaccio, , France

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Annonay, , France

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Arras, , France

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Auch, , France

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Aurillac, , France

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Beauvais, , France

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Beauvais, , France

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Bois-Bernard, , France

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Bordeaux, , France

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Bourg-en-Bresse, , France

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Bourgoin, , France

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Brest, , France

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Chamalières, , France

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Chaumont, , France

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Clermont-Ferrand, , France

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Clermont-Ferrand, , France

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Colmar, , France

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Condom, , France

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Dijon, , France

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Dourlers, , France

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Épinal, , France

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Fleurance, , France

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Fourmies, , France

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Gap, , France

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Gradignan, , France

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Haguenau, , France

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La Roche-sur-Yon, , France

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La Tronche, , France

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Le Mans, , France

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Le Puy-en-Velay, , France

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Libourne, , France

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Lille, , France

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Maubeuge, , France

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Meaux, , France

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Mirande, , France

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Montereau, , France

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Nantes, , France

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Nantes, , France

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Neuilly-sur-Seine, , France

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Nîmes, , France

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Nogaro, , France

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Noyal-Pontivy, , France

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Olivet, , France

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Orléans, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Poitiers, , France

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Quimper, , France

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Quincy-sous-Sénart, , France

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Rambouillet, , France

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Rennes, , France

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Rezé, , France

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Roubaix, , France

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Rouen, , France

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Saint-Brieuc, , France

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Saint-Laurent-du-Var, , France

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Saint-Lô, , France

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Saint-Marcel, , France

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Saint-Nazaire, , France

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Saint-Ouen, , France

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Saint-Priest-en-Jarez, , France

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Salouël, , France

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Saran, , France

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Stains, , France

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Strasbourg, , France

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Toulouse, , France

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Tourcoing, , France

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Valenciennes, , France

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Vandœuvre-lès-Nancy, , France

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Vesoul, , France

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Villefranche-de-Rouergue, , France

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Yssingeaux, , France

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Countries

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France

Other Identifiers

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ML28980

Identifier Type: -

Identifier Source: org_study_id