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)

July 11, 2019 updated by: Hoffmann-La Roche

A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

551

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix En Provence, France, 13100
        • CHP Aix
      • Ajaccio, France, 20303
        • Ch Notre Dame Misericorde; Hemodialyse
      • Alencon, France, 61014
        • Chi D Alencon;Nephrologie Hemodialyse
      • Ales, France, 30100
        • Centre Aider
      • Angers, France, 49933
        • Hotel Dieu; Nephrologie Hemodialyse
      • Annonay, France, 07103
        • Centre Hospitalier; Hemodialyse
      • Antibes, France, 06600
        • Centre Hemodialyse La Riviera
      • Arras, France, 62022
        • Ch D Arras; Nephrologie
      • Aubagne, France, 13400
        • Chp Aubagne
      • Avignon, France, 84902
        • Ch Henri Duffaut; Nephrologie Hemodialyse
      • Bayonne, France, 64109
        • Chic Cote Basque Bayonne; Nephrologie Hemodialyse
      • Beauvais, France, 60021
        • Ch De Beauvais; Neph Endocrino Dialyse Diabeto
      • Belley, France, 01300
        • Centre D Hemodialyse Regina
      • Besancon, France, 25030
        • CHU Saint Jacques; Centre De Dialyse
      • Beuvry, France, 62660
        • Ch Germon Et Gauthier; Medecine Interne Nephrologie
      • Beziers, France
        • CNB - Centre Nephrologie Du Biterrois
      • Bordeaux, France, 33076
        • Hopital Pellegrin; Departement Nephrologie
      • Bordeaux, France, 33000
        • Centre Hemodialyse St Augustin; Nephrologie
      • Bordeaux, France, 33300
        • Cabinet Médical
      • Bourg En Bresse, France, 01012
        • Ch De Fleyriat; Nephrologie Hemodialyse
      • Bourgoin Jallieu, France, 38317
        • Aural; Service Hemodialyse
      • Brest, France, 29609
        • Hopital La Cavale Blanche; Nephrologie
      • Brive La Gaillarde, France, 19312
        • Ch de Brive la Gaillarde; Nephrologie Hemodialyse
      • Cabestany, France, 66330
        • Centre D Hemodialyse Saint Roch
      • Caen, France, 14033
        • Hopital Clemenceau; Nephrologie Hemodialyse
      • Carcassonne, France, 11890
        • Ch Antoine Gayraud; Nephrologie Hemodialyse
      • Castelnau le Lez, France, 34170
        • Centre Hemodialyse Du Lez; Nephrologie
      • Chalon Sur Saone, France, 71100
        • CH William Morey; Nephrologie
      • Chamalieres, France, 63400
        • Aura Auvergne; Aura Auvergne
      • Chambery, France, 73011
        • Ch De Chambery; Nephrologie
      • Chateauroux, France, 36000
        • Avitum France; Centre De Nephrologie
      • Cholet, France, 49300
        • Centre Hospitalier; Hemodialyse
      • Clermont Ferrand, France, 63100
        • Centre De Sante Medical; Centre De Sante Republique
      • Clermont-ferrand, France, 63003
        • Hôpital Gabriel Montpied
      • Creil, France, 60109
        • Ch Laennec; Nephrologie Hemodialyse
      • Dijon, France, 21000
        • Fondation Transplantation; Ctirc De Drevon
      • Etampes, France, 91150
        • Nephrocare Ile De France; Etampes
      • Evreux, France, 27023
        • Chi Eure Seine D Evreux; Nephrologie
      • Fontaine Les Dijon, France, 21121
        • Cabinet Médical
      • Freyming Merlebach, France, 57804
        • Hopital De Freyming; Nephrologie
      • GAP, France, 05000
        • Centre Hospitalier General; Service de Nephrologie-Hemodialyse
      • Gradignan, France, 33171
        • Association Aurad Aquitaine; Aurad Gradignan
      • Greize, France, 69400
        • Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse
      • La Roche Sur Yon, France, 85925
        • Ch Dptal Les Oudairies; Nephrologie
      • La Tronche, France, 38700
        • Hopital Albert Michallon; Clinique De Nephrologie
      • La Tronche, France, 38701
        • Agduc Muller
      • Laon, France, 02001
        • Ch De Laon; Nephrologie Hemodialyse
      • Le Havre, France, 76620
        • Hopital Prive De L Estuaire; Nephrologie Hemodialyse
      • Le Puy En Velay, France, 43012
        • Ch Emile Roux; Nephrologie
      • Lille, France, 59037
        • Hopital Claude Huriez; Nephrologie
      • Lille, France, 59042
        • Polyclinique De La Louviere; Nephrologie
      • Lyon, France, 69437
        • Hopital Edouard-Herriot; Nephrologie - Hemodialyse
      • Lyon, France, 69365
        • Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse
      • Marseille, France, 13253
        • Clinique Bouchard ; Nephrologie
      • Marseille, France, 13385
        • Hopital De La Conception; Hemodialyse
      • Marseille, France, 13385
        • Hopital De La Conception; Nephrologie
      • Meaux, France, 77104
        • Ch De Meaux; Medecine C
      • Mont De Marsan, France, 40024
        • Hopital Layne; Nephrologie Hemodialyse
      • Mont St Martin, France, 54350
        • Hopital Hotel Dieu; Medecine Geriatrique Nephrologie
      • Montereau, France, 77871
        • Centre D Hemodialyse Sodetir
      • Montpellier, France, 34295
        • Centre Aider; Centre Aider Montpellier
      • Mullhouse, France, 68100
        • Centre De Dialyse La Fonderie
      • Nancy, France, 54100
        • Polyclinique De Gentilly; Hemodialyse
      • Nantes, France, 44035
        • Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
      • Nantes, France, 44093
        • Hopital Hotel Dieu Et Hme; Hemodialyse Chronique
      • Nantes, France, 44202
        • Echo Nantes Confluent; Uad Montfort
      • Nice, France, 06002
        • Hopital Pasteur; Pavillon A Nephrologie
      • Nimes, France, 30900
        • Centre Gardialyse
      • Orleans, France, 45000
        • Ctre Dialyse De La Reine Blanche
      • Orleans, France, 45100
        • Hopital de La Source; Service de Nephrologie & Hemodialyse
      • Paris, France, 75475
        • Hopital Saint Louis; Service de Nephrologie - Transplantation
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou; Service de Nephrologie
      • Paris, France, 75651
        • Ch Pitie Salpetriere; Nephrologie Hemodialyse
      • Paris, France, 75970
        • Hopital Tenon; Nephrologie Dialyse
      • Perpignan, France, 66046
        • Hopital Saint Jean; Nephrologie
      • Pessac, France, 33608
        • Centre Hemodialyse Saint Martin
      • Pierre Benite, France, 69495
        • Ch Lyon Sud; Nephrologie Sect Jules Courmont
      • Poissy, France, 78303
        • Chi Poissy Saint Germain En Laye; Hemodialyse
      • Poitiers, France, 86021
        • Chu La Miletrie;Nephrologie Transplantation
      • Quimper, France, 29000
        • Association Pour L'Aide Des Uremiques de Bretagne
      • Rennes, France, 35033
        • Hopital Pontchaillou; Nephrologie
      • Rouen, France, 76040
        • Clinique De L Europe; Hemodialyse
      • Saint Laurent Du Var, France, 06721
        • Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse
      • Saint Lo, France, 50009
        • Memorial France Etats Unis; Nephrologie
      • Saint-malo, France, 35043
        • Hopital Broussais; Medecine 4
      • Sainte Foy les Lyon, France, 69110
        • Nephrocare Tassin Charcot; Nephrologie
      • Salouel, France, 80480
        • Hopital Sud ; Nephrologie Hemodialyse
      • Sens, France, 89100
        • Centre Hospitalier De Sens; Nephrologie-Dialyse
      • Sens, France, 89100
        • Ch Gaston Ramon; Nephrologie
      • Soissons, France, 02209
        • Ch De Soissons; Medecine 5
      • St Jean De Verges, France, 09000
        • Chi Du Val D Ariege; Gastro Enterologie Nephrologie
      • St Laurent Du Var, France, 06700
        • Centre D Hemodialyse
      • St Laurent Du Var, France, 06721
        • Institut Arnault Tzanck; Med 2
      • St Priest En Jarez, France, 42270
        • Artic; Bureau
      • St Priest En Jarez, France, 42277
        • Hopital Nord; Hopital De Jour
      • St Priest En Jarez, France, 42277
        • HOPITAL NORD; NEPH Transplantation Reanimation
      • Strasbourg, France, 67091
        • Hopital Civil; Nephrologie Clinique Medicale B
      • Suresnes, France, 92150
        • Nephrocare Ile de France; Suresnes
      • Suresnes, France, 92151
        • Hopital Foch; Nephrologie Hemodialyse
      • Tarbes, France, 65013
        • Hopital de La Gespe; Dept of Nephrology
      • Thonon-les-bains, France, 74203
        • Hopitaux Du Leman Site Thonon;Nephrologie
      • Toulon, France, 83056
        • Hopital Sainte Musse; Nephrologie
      • Toulouse, France, 31059
        • Hopital Rangueil; Nephrologie Hemodialyse
      • Tournan-en-brie, France, 77220
        • Clinique de Tournan; Service de Nephrologie
      • Tours, France, 37044
        • Hopital Bretonneau; Nephrologie Transplantations
      • Vannes, France, 56017
        • Ch Bretagne Atlantique De Vannes; Nephrologie
      • Verdun, France, 55107
        • Hopital Saint Nicolas; Medecine A
      • Villeurbanne, France, 69200
        • Cabinet Médical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESA naïve participants with chronic kidney disease who are not on dialysis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse
Time Frame: Baseline, Month 9
Baseline, Month 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin Levels According to Liu Index and Resistance Factors
Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Average Dose of Mircera in Total Population
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Duration of Treatment With Mircera
Time Frame: Baseline up to 9 months
Baseline up to 9 months
Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia
Time Frame: Baseline up to 9 month
Baseline up to 9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 21, 2012

Primary Completion (ACTUAL)

March 25, 2015

Study Completion (ACTUAL)

March 25, 2015

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (ESTIMATE)

December 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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