A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

NCT ID: NCT01756612

Last Updated: 2019-07-15

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

551 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-21

Study Completion Date

2015-03-25

Brief Summary

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This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

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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Chronic Kidney Disease Participants

Participants for whom the treating physician has decided to initiate treatment with MIRCERA for medical reasons prior to study start, will be observed for 9 months.

Methoxy Polyethylene Glycol-Epoetin Beta

Intervention Type DRUG

Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.

Interventions

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Methoxy Polyethylene Glycol-Epoetin Beta

Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.

Intervention Type DRUG

Other Intervention Names

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Mircera

Eligibility Criteria

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Inclusion Criteria

* Participants with chronic kidney disease not on dialysis
* Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study
* Hemoglobin level less then (\<)10 grams per deciliter (g/dL) at inclusion
* Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start

Exclusion Criteria

* Functional renal transplant
* Current participation in a clinical trial in anemia due to chronic kidney disease
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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CHP Aix

Aix-en-Provence, , France

Site Status

Ch Notre Dame Misericorde; Hemodialyse

Ajaccio, , France

Site Status

Chi D Alencon;Nephrologie Hemodialyse

Alençon, , France

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Centre Aider

Alès, , France

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Hotel Dieu; Nephrologie Hemodialyse

Angers, , France

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Centre Hospitalier; Hemodialyse

Annonay, , France

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Centre Hemodialyse La Riviera

Antibes, , France

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Ch D Arras; Nephrologie

Arras, , France

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Chp Aubagne

Aubagne, , France

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Ch Henri Duffaut; Nephrologie Hemodialyse

Avignon, , France

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Chic Cote Basque Bayonne; Nephrologie Hemodialyse

Bayonne, , France

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Ch De Beauvais; Neph Endocrino Dialyse Diabeto

Beauvais, , France

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Centre D Hemodialyse Regina

Belley, , France

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CHU Saint Jacques; Centre De Dialyse

Besançon, , France

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Ch Germon Et Gauthier; Medecine Interne Nephrologie

Beuvry, , France

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CNB - Centre Nephrologie Du Biterrois

Béziers, , France

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Centre Hemodialyse St Augustin; Nephrologie

Bordeaux, , France

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Hopital Pellegrin; Departement Nephrologie

Bordeaux, , France

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Cabinet Medical

Bordeaux, , France

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Ch De Fleyriat; Nephrologie Hemodialyse

Bourg-en-Bresse, , France

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Aural; Service Hemodialyse

Bourgoin, , France

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Hopital La Cavale Blanche; Nephrologie

Brest, , France

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Ch de Brive la Gaillarde; Nephrologie Hemodialyse

Brive-la-Gaillarde, , France

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Centre D Hemodialyse Saint Roch

Cabestany, , France

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Hopital Clemenceau; Nephrologie Hemodialyse

Caen, , France

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Ch Antoine Gayraud; Nephrologie Hemodialyse

Carcassonne, , France

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Centre Hemodialyse Du Lez; Nephrologie

Castelnau-le-Lez, , France

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CH William Morey; Nephrologie

Chalon-sur-Saône, , France

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Aura Auvergne; Aura Auvergne

Chamalières, , France

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Ch De Chambery; Nephrologie

Chambéry, , France

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Avitum France; Centre De Nephrologie

Châteauroux, , France

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Centre Hospitalier; Hemodialyse

Cholet, , France

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Hopital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Centre De Sante Medical; Centre De Sante Republique

Clermont-Ferrand, , France

Site Status

Ch Laennec; Nephrologie Hemodialyse

Creil, , France

Site Status

Fondation Transplantation; Ctirc De Drevon

Dijon, , France

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Nephrocare Ile De France; Etampes

Étampes, , France

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Chi Eure Seine D Evreux; Nephrologie

Évreux, , France

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Cabinet Medical

Fontaine-lès-Dijon, , France

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Hopital De Freyming; Nephrologie

Freyming-Merlebach, , France

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Centre Hospitalier General; Service de Nephrologie-Hemodialyse

Gap, , France

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Association Aurad Aquitaine; Aurad Gradignan

Gradignan, , France

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Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse

Greize, , France

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Ch Dptal Les Oudairies; Nephrologie

La Roche-sur-Yon, , France

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Hopital Albert Michallon; Clinique De Nephrologie

La Tronche, , France

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Agduc Muller

La Tronche, , France

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Ch De Laon; Nephrologie Hemodialyse

Laon, , France

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Hopital Prive De L Estuaire; Nephrologie Hemodialyse

Le Havre, , France

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Ch Emile Roux; Nephrologie

Le Puy-en-Velay, , France

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Hopital Claude Huriez; Nephrologie

Lille, , France

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Polyclinique De La Louviere; Nephrologie

Lille, , France

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Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse

Lyon, , France

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Hopital Edouard-Herriot; Nephrologie - Hemodialyse

Lyon, , France

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Clinique Bouchard ; Nephrologie

Marseille, , France

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Hopital De La Conception; Hemodialyse

Marseille, , France

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Hopital De La Conception; Nephrologie

Marseille, , France

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Ch De Meaux; Medecine C

Meaux, , France

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Hopital Layne; Nephrologie Hemodialyse

Mont-de-Marsan, , France

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Hopital Hotel Dieu; Medecine Geriatrique Nephrologie

Mont-Saint-Martin, , France

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Centre D Hemodialyse Sodetir

Montereau, , France

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Centre Aider; Centre Aider Montpellier

Montpellier, , France

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Centre De Dialyse La Fonderie

Mullhouse, , France

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Polyclinique De Gentilly; Hemodialyse

Nancy, , France

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Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

Nantes, , France

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Hopital Hotel Dieu Et Hme; Hemodialyse Chronique

Nantes, , France

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Echo Nantes Confluent; Uad Montfort

Nantes, , France

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Hopital Pasteur; Pavillon A Nephrologie

Nice, , France

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Centre Gardialyse

Nîmes, , France

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Ctre Dialyse De La Reine Blanche

Orléans, , France

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Hopital de La Source; Service de Nephrologie & Hemodialyse

Orléans, , France

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Hopital Saint Louis; Service de Nephrologie - Transplantation

Paris, , France

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Ch Pitie Salpetriere; Nephrologie Hemodialyse

Paris, , France

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Hopital Europeen Georges Pompidou; Service de Nephrologie

Paris, , France

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Hopital Tenon; Nephrologie Dialyse

Paris, , France

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Hopital Saint Jean; Nephrologie

Perpignan, , France

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Centre Hemodialyse Saint Martin

Pessac, , France

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Ch Lyon Sud; Nephrologie Sect Jules Courmont

Pierre-Bénite, , France

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Chi Poissy Saint Germain En Laye; Hemodialyse

Poissy, , France

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Chu La Miletrie;Nephrologie Transplantation

Poitiers, , France

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Association Pour L'Aide Des Uremiques de Bretagne

Quimper, , France

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Hopital Pontchaillou; Nephrologie

Rennes, , France

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Clinique De L Europe; Hemodialyse

Rouen, , France

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Chi Du Val D Ariege; Gastro Enterologie Nephrologie

Saint-Jean-de-Verges, , France

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Centre D Hemodialyse

Saint-Laurent-du-Var, , France

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Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse

Saint-Laurent-du-Var, , France

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Institut Arnault Tzanck; Med 2

Saint-Laurent-du-Var, , France

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Memorial France Etats Unis; Nephrologie

Saint-Lô, , France

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Artic; Bureau

Saint-Priest-en-Jarez, , France

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Hopital Nord; Hopital De Jour

Saint-Priest-en-Jarez, , France

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HOPITAL NORD; NEPH Transplantation Reanimation

Saint-Priest-en-Jarez, , France

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Nephrocare Tassin Charcot; Nephrologie

Sainte-Foy-lès-Lyon, , France

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Hopital Sud ; Nephrologie Hemodialyse

Salouël, , France

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Centre Hospitalier De Sens; Nephrologie-Dialyse

Sens, , France

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Ch Gaston Ramon; Nephrologie

Sens, , France

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Ch De Soissons; Medecine 5

Soissons, , France

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Hopital Broussais; Medecine 4

St-Malo, , France

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Hopital Civil; Nephrologie Clinique Medicale B

Strasbourg, , France

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Nephrocare Ile de France; Suresnes

Suresnes, , France

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Hopital Foch; Nephrologie Hemodialyse

Suresnes, , France

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Hopital de La Gespe; Dept of Nephrology

Tarbes, , France

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Hopitaux Du Leman Site Thonon;Nephrologie

Thonon-les-Bains, , France

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Hopital Sainte Musse; Nephrologie

Toulon, , France

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Hopital Rangueil; Nephrologie Hemodialyse

Toulouse, , France

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Clinique de Tournan; Service de Nephrologie

Tournan-en-Brie, , France

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Hopital Bretonneau; Nephrologie Transplantations

Tours, , France

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Ch Bretagne Atlantique De Vannes; Nephrologie

Vannes, , France

Site Status

Hopital Saint Nicolas; Medecine A

Verdun, , France

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Cabinet Medical

Villeurbanne, , France

Site Status

Countries

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France

Other Identifiers

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ML28145

Identifier Type: -

Identifier Source: org_study_id

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