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Clinical Trial Details

Trial ID: L0907
Source ID: NCT01756612
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Title: 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)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Renal Anemia of Chronic Kidney Disease
Interventions: DRUG: Methoxy Polyethylene Glycol-Epoetin Beta
Outcome Measures: Primary: 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: 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|Duration of Treatment With Mircera, Baseline up to 9 months|Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia, Baseline up to 9 month
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 551
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2012-11-21
Completion Date: 2015-03-25
Results First Posted:
Last Update Posted: 2019-07-15
Locations: CHP Aix, Aix En Provence, 13100, France|Ch Notre Dame Misericorde; Hemodialyse, Ajaccio, 20303, France|Chi D Alencon;Nephrologie Hemodialyse, Alencon, 61014, France|Centre Aider, Ales, 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, Besancon, 25030, France|Ch Germon Et Gauthier; Medecine Interne Nephrologie, Beuvry, 62660, France|CNB - Centre Nephrologie Du Biterrois, Beziers, 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 Jallieu, 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 Saone, 71100, France|Aura Auvergne; Aura Auvergne, Chamalieres, 63400, France|Ch De Chambery; Nephrologie, Chambery, 73011, France|Avitum France; Centre De Nephrologie, Chateauroux, 36000, France|Centre Hospitalier; Hemodialyse, Cholet, 49300, France|Centre De Sante Medical; Centre De Sante Republique, Clermont Ferrand, 63100, France|Hopital Gabriel Montpied, Clermont-ferrand, 63003, France|Ch Laennec; Nephrologie Hemodialyse, Creil, 60109, France|Fondation Transplantation; Ctirc De Drevon, Dijon, 21000, France|Nephrocare Ile De France; Etampes, Etampes, 91150, France|Chi Eure Seine D Evreux; Nephrologie, Evreux, 27023, France|Cabinet Medical, Fontaine Les 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 St 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, Nimes, 30900, France|Ctre Dialyse De La Reine Blanche, Orleans, 45000, France|Hopital de La Source; Service de Nephrologie & Hemodialyse, Orleans, 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 Benite, 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|Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse, Saint Laurent Du Var, 06721, France|Memorial France Etats Unis; Nephrologie, Saint Lo, 50009, France|Hopital Broussais; Medecine 4, Saint-malo, 35043, France|Nephrocare Tassin Charcot; Nephrologie, Sainte Foy les Lyon, 69110, France|Hopital Sud ; Nephrologie Hemodialyse, Salouel, 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|Chi Du Val D Ariege; Gastro Enterologie Nephrologie, St Jean De Verges, 09000, France|Centre D Hemodialyse, St Laurent Du Var, 06700, France|Institut Arnault Tzanck; Med 2, St Laurent Du Var, 06721, France|Artic; Bureau, St Priest En Jarez, 42270, France|Hopital Nord; Hopital De Jour, St Priest En Jarez, 42277, France|HOPITAL NORD; NEPH Transplantation Reanimation, St Priest En Jarez, 42277, 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
URL: https://clinicaltrials.gov/show/NCT01756612

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress