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)
- Conditions
- Renal Anemia of Chronic Kidney Disease
- Interventions
- Registration Number
- NCT01756612
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
- 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
- Functional renal transplant
- Current participation in a clinical trial in anemia due to chronic kidney disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Kidney Disease Participants Methoxy Polyethylene Glycol-Epoetin Beta 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Hemoglobin Levels According to Liu Index and Resistance Factors Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 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
Trial Locations
- Locations (105)
Hopital Claude Huriez; Nephrologie
🇫🇷Lille, France
Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse
🇫🇷Lyon, France
Polyclinique De La Louviere; Nephrologie
🇫🇷Lille, France
Echo Nantes Confluent; Uad Montfort
🇫🇷Nantes, France
Hopital Broussais; Medecine 4
🇫🇷Saint-malo, France
Hopital Bretonneau; Nephrologie Transplantations
🇫🇷Tours, France
Nephrocare Ile de France; Suresnes
🇫🇷Suresnes, France
Hopital Saint Nicolas; Medecine A
🇫🇷Verdun, France
Centre Hospitalier; Hemodialyse
🇫🇷Cholet, France
Chp Aubagne
🇫🇷Aubagne, France
Ch Henri Duffaut; Nephrologie Hemodialyse
🇫🇷Avignon, France
Ch De Beauvais; Neph Endocrino Dialyse Diabeto
🇫🇷Beauvais, France
Cabinet Medical
🇫🇷Villeurbanne, France
Ch De Fleyriat; Nephrologie Hemodialyse
🇫🇷Bourg En Bresse, France
Aura Auvergne; Aura Auvergne
🇫🇷Chamalieres, France
Centre De Sante Medical; Centre De Sante Republique
🇫🇷Clermont Ferrand, France
Chi Eure Seine D Evreux; Nephrologie
🇫🇷Evreux, France
Hopital Gabriel Montpied
🇫🇷Clermont-ferrand, France
Hopital De Freyming; Nephrologie
🇫🇷Freyming Merlebach, France
Hopital Layne; Nephrologie Hemodialyse
🇫🇷Mont De Marsan, France
Hopital Prive De L Estuaire; Nephrologie Hemodialyse
🇫🇷Le Havre, France
Hopital Hotel Dieu; Medecine Geriatrique Nephrologie
🇫🇷Mont St Martin, France
Hopital Europeen Georges Pompidou; Service de Nephrologie
🇫🇷Paris, France
Hopital Saint Jean; Nephrologie
🇫🇷Perpignan, France
Chi Poissy Saint Germain En Laye; Hemodialyse
🇫🇷Poissy, France
Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse
🇫🇷Saint Laurent Du Var, France
Chu La Miletrie;Nephrologie Transplantation
🇫🇷Poitiers, France
Memorial France Etats Unis; Nephrologie
🇫🇷Saint Lo, France
Nephrocare Tassin Charcot; Nephrologie
🇫🇷Sainte Foy les Lyon, France
Association Pour L'Aide Des Uremiques de Bretagne
🇫🇷Quimper, France
Hopital Pontchaillou; Nephrologie
🇫🇷Rennes, France
Clinique De L Europe; Hemodialyse
🇫🇷Rouen, France
Hopital Sud ; Nephrologie Hemodialyse
🇫🇷Salouel, France
Chi Du Val D Ariege; Gastro Enterologie Nephrologie
🇫🇷St Jean De Verges, France
Centre D Hemodialyse
🇫🇷St Laurent Du Var, France
Ch Gaston Ramon; Nephrologie
🇫🇷Sens, France
Ch De Soissons; Medecine 5
🇫🇷Soissons, France
Artic; Bureau
🇫🇷St Priest En Jarez, France
Institut Arnault Tzanck; Med 2
🇫🇷St Laurent Du Var, France
Hopital Nord; Hopital De Jour
🇫🇷St Priest En Jarez, France
HOPITAL NORD; NEPH Transplantation Reanimation
🇫🇷St Priest En Jarez, France
Hopital Civil; Nephrologie Clinique Medicale B
🇫🇷Strasbourg, France
Hopital Foch; Nephrologie Hemodialyse
🇫🇷Suresnes, France
Hopital de La Gespe; Dept of Nephrology
🇫🇷Tarbes, France
Hopitaux Du Leman Site Thonon;Nephrologie
🇫🇷Thonon-les-bains, France
Hopital Sainte Musse; Nephrologie
🇫🇷Toulon, France
Ch Bretagne Atlantique De Vannes; Nephrologie
🇫🇷Vannes, France
Clinique de Tournan; Service de Nephrologie
🇫🇷Tournan-en-brie, France
Hopital Rangueil; Nephrologie Hemodialyse
🇫🇷Toulouse, France
Centre Aider
🇫🇷Ales, France
CHU Saint Jacques; Centre De Dialyse
🇫🇷Besancon, France
Centre D Hemodialyse Regina
🇫🇷Belley, France
Ch Notre Dame Misericorde; Hemodialyse
🇫🇷Ajaccio, France
CHP Aix
🇫🇷Aix En Provence, France
Chi D Alencon;Nephrologie Hemodialyse
🇫🇷Alencon, France
Ch D Arras; Nephrologie
🇫🇷Arras, France
Hotel Dieu; Nephrologie Hemodialyse
🇫🇷Angers, France
Centre Hemodialyse La Riviera
🇫🇷Antibes, France
Chic Cote Basque Bayonne; Nephrologie Hemodialyse
🇫🇷Bayonne, France
CNB - Centre Nephrologie Du Biterrois
🇫🇷Beziers, France
Ch Germon Et Gauthier; Medecine Interne Nephrologie
🇫🇷Beuvry, France
Centre Hemodialyse St Augustin; Nephrologie
🇫🇷Bordeaux, France
Hopital Pellegrin; Departement Nephrologie
🇫🇷Bordeaux, France
Aural; Service Hemodialyse
🇫🇷Bourgoin Jallieu, France
Centre D Hemodialyse Saint Roch
🇫🇷Cabestany, France
Ch de Brive la Gaillarde; Nephrologie Hemodialyse
🇫🇷Brive La Gaillarde, France
Centre Hemodialyse Du Lez; Nephrologie
🇫🇷Castelnau le Lez, France
Ch Antoine Gayraud; Nephrologie Hemodialyse
🇫🇷Carcassonne, France
Hopital Clemenceau; Nephrologie Hemodialyse
🇫🇷Caen, France
CH William Morey; Nephrologie
🇫🇷Chalon Sur Saone, France
Ch De Chambery; Nephrologie
🇫🇷Chambery, France
Avitum France; Centre De Nephrologie
🇫🇷Chateauroux, France
Ch Laennec; Nephrologie Hemodialyse
🇫🇷Creil, France
Fondation Transplantation; Ctirc De Drevon
🇫🇷Dijon, France
Nephrocare Ile De France; Etampes
🇫🇷Etampes, France
Association Aurad Aquitaine; Aurad Gradignan
🇫🇷Gradignan, France
Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse
🇫🇷Greize, France
Centre Hospitalier General; Service de Nephrologie-Hemodialyse
🇫🇷GAP, France
Ch Dptal Les Oudairies; Nephrologie
🇫🇷La Roche Sur Yon, France
Ch De Laon; Nephrologie Hemodialyse
🇫🇷Laon, France
Hopital Albert Michallon; Clinique De Nephrologie
🇫🇷La Tronche, France
Agduc Muller
🇫🇷La Tronche, France
Ch De Meaux; Medecine C
🇫🇷Meaux, France
Ch Emile Roux; Nephrologie
🇫🇷Le Puy En Velay, France
Hopital De La Conception; Hemodialyse
🇫🇷Marseille, France
Clinique Bouchard ; Nephrologie
🇫🇷Marseille, France
Hopital Edouard-Herriot; Nephrologie - Hemodialyse
🇫🇷Lyon, France
Centre D Hemodialyse Sodetir
🇫🇷Montereau, France
Centre De Dialyse La Fonderie
🇫🇷Mullhouse, France
Centre Aider; Centre Aider Montpellier
🇫🇷Montpellier, France
Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
🇫🇷Nantes, France
Hopital Hotel Dieu Et Hme; Hemodialyse Chronique
🇫🇷Nantes, France
Centre Gardialyse
🇫🇷Nimes, France
Hopital Pasteur; Pavillon A Nephrologie
🇫🇷Nice, France
Ctre Dialyse De La Reine Blanche
🇫🇷Orleans, France
Hopital de La Source; Service de Nephrologie & Hemodialyse
🇫🇷Orleans, France
Hopital Saint Louis; Service de Nephrologie - Transplantation
🇫🇷Paris, France
Hopital Tenon; Nephrologie Dialyse
🇫🇷Paris, France
Centre Hospitalier De Sens; Nephrologie-Dialyse
🇫🇷Sens, France
Hopital De La Conception; Nephrologie
🇫🇷Marseille, France
Polyclinique De Gentilly; Hemodialyse
🇫🇷Nancy, France
Ch Pitie Salpetriere; Nephrologie Hemodialyse
🇫🇷Paris, France
Centre Hemodialyse Saint Martin
🇫🇷Pessac, France
Hopital La Cavale Blanche; Nephrologie
🇫🇷Brest, France
Ch Lyon Sud; Nephrologie Sect Jules Courmont
🇫🇷Pierre Benite, France