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)
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®
1 other identifier
observational
551
1 country
108
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Typical duration for all trials
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2015
CompletedJuly 15, 2019
July 1, 2019
2.3 years
December 19, 2012
July 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline, Month 9
Secondary Outcomes (7)
Hemoglobin Levels According to Liu Index and Resistance Factors
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Average Dose of Mircera in Total Population
Baseline up to 9 months
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population
Baseline up to 9 months
Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation
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
Baseline up to 9 months
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.
Eligibility Criteria
ESA naïve participants with chronic kidney disease who are not on dialysis
You may qualify if:
- Participants with chronic kidney disease not on dialysis
- Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start
You may not qualify if:
- Functional renal transplant
- Current participation in a clinical trial in anemia due to chronic kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
CHP Aix
Aix-en-Provence, 13100, France
Ch Notre Dame Misericorde; Hemodialyse
Ajaccio, 20303, France
Chi D Alencon;Nephrologie Hemodialyse
Alençon, 61014, France
Centre Aider
Alès, 30100, France
Hotel Dieu; Nephrologie Hemodialyse
Angers, 49933, France
Centre Hospitalier; Hemodialyse
Annonay, 07103, France
Centre Hemodialyse La Riviera
Antibes, 06600, France
Ch D Arras; Nephrologie
Arras, 62022, France
Chp Aubagne
Aubagne, 13400, France
Ch Henri Duffaut; Nephrologie Hemodialyse
Avignon, 84902, France
Chic Cote Basque Bayonne; Nephrologie Hemodialyse
Bayonne, 64109, France
Ch De Beauvais; Neph Endocrino Dialyse Diabeto
Beauvais, 60021, France
Centre D Hemodialyse Regina
Belley, 01300, France
CHU Saint Jacques; Centre De Dialyse
Besançon, 25030, France
Ch Germon Et Gauthier; Medecine Interne Nephrologie
Beuvry, 62660, France
CNB - Centre Nephrologie Du Biterrois
Béziers, France
Centre Hemodialyse St Augustin; Nephrologie
Bordeaux, 33000, France
Hopital Pellegrin; Departement Nephrologie
Bordeaux, 33076, France
Cabinet Medical
Bordeaux, 33300, France
Ch De Fleyriat; Nephrologie Hemodialyse
Bourg-en-Bresse, 01012, France
Aural; Service Hemodialyse
Bourgoin, 38317, France
Hopital La Cavale Blanche; Nephrologie
Brest, 29609, France
Ch de Brive la Gaillarde; Nephrologie Hemodialyse
Brive-la-Gaillarde, 19312, France
Centre D Hemodialyse Saint Roch
Cabestany, 66330, France
Hopital Clemenceau; Nephrologie Hemodialyse
Caen, 14033, France
Ch Antoine Gayraud; Nephrologie Hemodialyse
Carcassonne, 11890, France
Centre Hemodialyse Du Lez; Nephrologie
Castelnau-le-Lez, 34170, France
CH William Morey; Nephrologie
Chalon-sur-Saône, 71100, France
Aura Auvergne; Aura Auvergne
Chamalières, 63400, France
Ch De Chambery; Nephrologie
Chambéry, 73011, France
Avitum France; Centre De Nephrologie
Châteauroux, 36000, France
Centre Hospitalier; Hemodialyse
Cholet, 49300, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre De Sante Medical; Centre De Sante Republique
Clermont-Ferrand, 63100, France
Ch Laennec; Nephrologie Hemodialyse
Creil, 60109, France
Fondation Transplantation; Ctirc De Drevon
Dijon, 21000, France
Nephrocare Ile De France; Etampes
Étampes, 91150, France
Chi Eure Seine D Evreux; Nephrologie
Évreux, 27023, France
Cabinet Medical
Fontaine-lès-Dijon, 21121, France
Hopital De Freyming; Nephrologie
Freyming-Merlebach, 57804, France
Centre Hospitalier General; Service de Nephrologie-Hemodialyse
Gap, 05000, France
Association Aurad Aquitaine; Aurad Gradignan
Gradignan, 33171, France
Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse
Greize, 69400, France
Ch Dptal Les Oudairies; Nephrologie
La Roche-sur-Yon, 85925, France
Hopital Albert Michallon; Clinique De Nephrologie
La Tronche, 38700, France
Agduc Muller
La Tronche, 38701, France
Ch De Laon; Nephrologie Hemodialyse
Laon, 02001, France
Hopital Prive De L Estuaire; Nephrologie Hemodialyse
Le Havre, 76620, France
Ch Emile Roux; Nephrologie
Le Puy-en-Velay, 43012, France
Hopital Claude Huriez; Nephrologie
Lille, 59037, France
Polyclinique De La Louviere; Nephrologie
Lille, 59042, France
Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse
Lyon, 69365, France
Hopital Edouard-Herriot; Nephrologie - Hemodialyse
Lyon, 69437, France
Clinique Bouchard ; Nephrologie
Marseille, 13253, France
Hopital De La Conception; Hemodialyse
Marseille, 13385, France
Hopital De La Conception; Nephrologie
Marseille, 13385, France
Ch De Meaux; Medecine C
Meaux, 77104, France
Hopital Layne; Nephrologie Hemodialyse
Mont-de-Marsan, 40024, France
Hopital Hotel Dieu; Medecine Geriatrique Nephrologie
Mont-Saint-Martin, 54350, France
Centre D Hemodialyse Sodetir
Montereau, 77871, France
Centre Aider; Centre Aider Montpellier
Montpellier, 34295, France
Centre De Dialyse La Fonderie
Mullhouse, 68100, France
Polyclinique De Gentilly; Hemodialyse
Nancy, 54100, France
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
Nantes, 44035, France
Hopital Hotel Dieu Et Hme; Hemodialyse Chronique
Nantes, 44093, France
Echo Nantes Confluent; Uad Montfort
Nantes, 44202, France
Hopital Pasteur; Pavillon A Nephrologie
Nice, 06002, France
Centre Gardialyse
Nîmes, 30900, France
Ctre Dialyse De La Reine Blanche
Orléans, 45000, France
Hopital de La Source; Service de Nephrologie & Hemodialyse
Orléans, 45100, France
Hopital Saint Louis; Service de Nephrologie - Transplantation
Paris, 75475, France
Ch Pitie Salpetriere; Nephrologie Hemodialyse
Paris, 75651, France
Hopital Europeen Georges Pompidou; Service de Nephrologie
Paris, 75908, France
Hopital Tenon; Nephrologie Dialyse
Paris, 75970, France
Hopital Saint Jean; Nephrologie
Perpignan, 66046, France
Centre Hemodialyse Saint Martin
Pessac, 33608, France
Ch Lyon Sud; Nephrologie Sect Jules Courmont
Pierre-Bénite, 69495, France
Chi Poissy Saint Germain En Laye; Hemodialyse
Poissy, 78303, France
Chu La Miletrie;Nephrologie Transplantation
Poitiers, 86021, France
Association Pour L'Aide Des Uremiques de Bretagne
Quimper, 29000, France
Hopital Pontchaillou; Nephrologie
Rennes, 35033, France
Clinique De L Europe; Hemodialyse
Rouen, 76040, France
Chi Du Val D Ariege; Gastro Enterologie Nephrologie
Saint-Jean-de-Verges, 09000, France
Centre D Hemodialyse
Saint-Laurent-du-Var, 06700, France
Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse
Saint-Laurent-du-Var, 06721, France
Institut Arnault Tzanck; Med 2
Saint-Laurent-du-Var, 06721, France
Memorial France Etats Unis; Nephrologie
Saint-Lô, 50009, France
Artic; Bureau
Saint-Priest-en-Jarez, 42270, France
Hopital Nord; Hopital De Jour
Saint-Priest-en-Jarez, 42277, France
HOPITAL NORD; NEPH Transplantation Reanimation
Saint-Priest-en-Jarez, 42277, France
Nephrocare Tassin Charcot; Nephrologie
Sainte-Foy-lès-Lyon, 69110, France
Hopital Sud ; Nephrologie Hemodialyse
Salouël, 80480, France
Centre Hospitalier De Sens; Nephrologie-Dialyse
Sens, 89100, France
Ch Gaston Ramon; Nephrologie
Sens, 89100, France
Ch De Soissons; Medecine 5
Soissons, 02209, France
Hopital Broussais; Medecine 4
St-Malo, 35043, France
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, 67091, France
Nephrocare Ile de France; Suresnes
Suresnes, 92150, France
Hopital Foch; Nephrologie Hemodialyse
Suresnes, 92151, France
Hopital de La Gespe; Dept of Nephrology
Tarbes, 65013, France
Hopitaux Du Leman Site Thonon;Nephrologie
Thonon-les-Bains, 74203, France
Hopital Sainte Musse; Nephrologie
Toulon, 83056, France
Hopital Rangueil; Nephrologie Hemodialyse
Toulouse, 31059, France
Clinique de Tournan; Service de Nephrologie
Tournan-en-Brie, 77220, France
Hopital Bretonneau; Nephrologie Transplantations
Tours, 37044, France
Ch Bretagne Atlantique De Vannes; Nephrologie
Vannes, 56017, France
Hopital Saint Nicolas; Medecine A
Verdun, 55107, France
Cabinet Medical
Villeurbanne, 69200, France
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 27, 2012
Study Start
November 21, 2012
Primary Completion
March 25, 2015
Study Completion
March 25, 2015
Last Updated
July 15, 2019
Record last verified: 2019-07