Clinical trial NCT01756612: 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)
Official title: 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®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia of Chronic Kidney Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESA naïve participants with chronic kidney disease who are not on dialysis

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 9
Secondary outcomes:
measure: Hemoglobin Levels According to Liu Index and Resistance Factors
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
measure: Average Dose of Mircera in Total Population
timeFrame: Baseline up to 9 months
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population
timeFrame: Baseline up to 9 months
measure: Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation
timeFrame: Baseline up to 9 months
measure: 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
timeFrame: Baseline up to 9 months
measure: Duration of Treatment With Mircera
timeFrame: Baseline up to 9 months
measure: Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia
timeFrame: Baseline up to 9 month
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: CHP Aix
city: Ajaccio
country: France
facility: Ch Notre Dame Misericorde; Hemodialyse
city: Alencon
country: France
facility: Chi D Alencon;Nephrologie Hemodialyse
city: Ales
country: France
facility: Centre Aider
city: Angers
country: France
facility: Hotel Dieu; Nephrologie Hemodialyse
city: Annonay
country: France
facility: Centre Hospitalier; Hemodialyse
city: Antibes
country: France
facility: Centre Hemodialyse La Riviera
city: Arras
country: France
facility: Ch D Arras; Nephrologie
city: Aubagne
country: France
facility: Chp Aubagne
city: Avignon
country: France
facility: Ch Henri Duffaut; Nephrologie Hemodialyse
city: Bayonne
country: France
facility: Chic Cote Basque Bayonne; Nephrologie Hemodialyse
city: Beauvais
country: France
facility: Ch De Beauvais; Neph Endocrino Dialyse Diabeto
city: Belley
country: France
facility: Centre D Hemodialyse Regina
city: Besancon
country: France
facility: CHU Saint Jacques; Centre De Dialyse
city: Beuvry
country: France
facility: Ch Germon Et Gauthier; Medecine Interne Nephrologie
city: Beziers
country: France
facility: CNB - Centre Nephrologie Du Biterrois
city: Bordeaux
country: France
facility: Centre Hemodialyse St Augustin; Nephrologie
city: Bordeaux
country: France
facility: Hopital Pellegrin; Departement Nephrologie
city: Bordeaux
country: France
facility: Cabinet Medical
city: Bourg En Bresse
country: France
facility: Ch De Fleyriat; Nephrologie Hemodialyse
city: Bourgoin Jallieu
country: France
facility: Aural; Service Hemodialyse
city: Brest
country: France
facility: Hopital La Cavale Blanche; Nephrologie
city: Brive La Gaillarde
country: France
facility: Ch de Brive la Gaillarde; Nephrologie Hemodialyse
city: Cabestany
country: France
facility: Centre D Hemodialyse Saint Roch
city: Caen
country: France
facility: Hopital Clemenceau; Nephrologie Hemodialyse
city: Carcassonne
country: France
facility: Ch Antoine Gayraud; Nephrologie Hemodialyse
city: Castelnau le Lez
country: France
facility: Centre Hemodialyse Du Lez; Nephrologie
city: Chalon Sur Saone
country: France
facility: CH William Morey; Nephrologie
city: Chamalieres
country: France
facility: Aura Auvergne; Aura Auvergne
city: Chambery
country: France
facility: Ch De Chambery; Nephrologie
city: Chateauroux
country: France
facility: Avitum France; Centre De Nephrologie
city: Cholet
country: France
facility: Centre Hospitalier; Hemodialyse
city: Clermont Ferrand
country: France
facility: Centre De Sante Medical; Centre De Sante Republique
city: Clermont-ferrand
country: France
facility: Hopital Gabriel Montpied
city: Creil
country: France
facility: Ch Laennec; Nephrologie Hemodialyse
city: Dijon
country: France
facility: Fondation Transplantation; Ctirc De Drevon
city: Etampes
country: France
facility: Nephrocare Ile De France; Etampes
city: Evreux
country: France
facility: Chi Eure Seine D Evreux; Nephrologie
city: Fontaine Les Dijon
country: France
facility: Cabinet Medical
city: Freyming Merlebach
country: France
facility: Hopital De Freyming; Nephrologie
city: GAP
country: France
facility: Centre Hospitalier General; Service de Nephrologie-Hemodialyse
city: Gradignan
country: France
facility: Association Aurad Aquitaine; Aurad Gradignan
city: Greize
country: France
facility: Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse
city: La Roche Sur Yon
country: France
facility: Ch Dptal Les Oudairies; Nephrologie
city: La Tronche
country: France
facility: Hopital Albert Michallon; Clinique De Nephrologie
city: La Tronche
country: France
facility: Agduc Muller
city: Laon
country: France
facility: Ch De Laon; Nephrologie Hemodialyse
city: Le Havre
country: France
facility: Hopital Prive De L Estuaire; Nephrologie Hemodialyse
city: Le Puy En Velay
country: France
facility: Ch Emile Roux; Nephrologie
city: Lille
country: France
facility: Hopital Claude Huriez; Nephrologie
city: Lille
country: France
facility: Polyclinique De La Louviere; Nephrologie
city: Lyon
country: France
facility: Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse
city: Lyon
country: France
facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse
city: Marseille
country: France
facility: Clinique Bouchard ; Nephrologie
city: Marseille
country: France
facility: Hopital De La Conception; Hemodialyse
city: Marseille
country: France
facility: Hopital De La Conception; Nephrologie
city: Meaux
country: France
facility: Ch De Meaux; Medecine C
city: Mont De Marsan
country: France
facility: Hopital Layne; Nephrologie Hemodialyse
city: Mont St Martin
country: France
facility: Hopital Hotel Dieu; Medecine Geriatrique Nephrologie
city: Montereau
country: France
facility: Centre D Hemodialyse Sodetir
city: Montpellier
country: France
facility: Centre Aider; Centre Aider Montpellier
city: Mullhouse
country: France
facility: Centre De Dialyse La Fonderie
city: Nancy
country: France
facility: Polyclinique De Gentilly; Hemodialyse
city: Nantes
country: France
facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Hemodialyse Chronique
city: Nantes
country: France
facility: Echo Nantes Confluent; Uad Montfort
city: Nice
country: France
facility: Hopital Pasteur; Pavillon A Nephrologie
city: Nimes
country: France
facility: Centre Gardialyse
city: Orleans
country: France
facility: Ctre Dialyse De La Reine Blanche
city: Orleans
country: France
facility: Hopital de La Source; Service de Nephrologie & Hemodialyse
city: Paris
country: France
facility: Hopital Saint Louis; Service de Nephrologie - Transplantation
city: Paris
country: France
facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service de Nephrologie
city: Paris
country: France
facility: Hopital Tenon; Nephrologie Dialyse
city: Perpignan
country: France
facility: Hopital Saint Jean; Nephrologie
city: Pessac
country: France
facility: Centre Hemodialyse Saint Martin
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Nephrologie Sect Jules Courmont
city: Poissy
country: France
facility: Chi Poissy Saint Germain En Laye; Hemodialyse
city: Poitiers
country: France
facility: Chu La Miletrie;Nephrologie Transplantation
city: Quimper
country: France
facility: Association Pour L'Aide Des Uremiques de Bretagne
city: Rennes
country: France
facility: Hopital Pontchaillou; Nephrologie
city: Rouen
country: France
facility: Clinique De L Europe; Hemodialyse
city: Saint Laurent Du Var
country: France
facility: Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse
city: Saint Lo
country: France
facility: Memorial France Etats Unis; Nephrologie
city: Saint-malo
country: France
facility: Hopital Broussais; Medecine 4
city: Sainte Foy les Lyon
country: France
facility: Nephrocare Tassin Charcot; Nephrologie
city: Salouel
country: France
facility: Hopital Sud ; Nephrologie Hemodialyse
city: Sens
country: France
facility: Centre Hospitalier De Sens; Nephrologie-Dialyse
city: Sens
country: France
facility: Ch Gaston Ramon; Nephrologie
city: Soissons
country: France
facility: Ch De Soissons; Medecine 5
city: St Jean De Verges
country: France
facility: Chi Du Val D Ariege; Gastro Enterologie Nephrologie
city: St Laurent Du Var
country: France
facility: Centre D Hemodialyse
city: St Laurent Du Var
country: France
facility: Institut Arnault Tzanck; Med 2
city: St Priest En Jarez
country: France
facility: Artic; Bureau
city: St Priest En Jarez
country: France
facility: Hopital Nord; Hopital De Jour
city: St Priest En Jarez
country: France
facility: HOPITAL NORD; NEPH Transplantation Reanimation
city: Strasbourg
country: France
facility: Hopital Civil; Nephrologie Clinique Medicale B
city: Suresnes
country: France
facility: Nephrocare Ile de France; Suresnes
city: Suresnes
country: France
facility: Hopital Foch; Nephrologie Hemodialyse
city: Tarbes
country: France
facility: Hopital de La Gespe; Dept of Nephrology
city: Thonon-les-bains
country: France
facility: Hopitaux Du Leman Site Thonon;Nephrologie
city: Toulon
country: France
facility: Hopital Sainte Musse; Nephrologie
city: Toulouse
country: France
facility: Hopital Rangueil; Nephrologie Hemodialyse
city: Tournan-en-brie
country: France
facility: Clinique de Tournan; Service de Nephrologie
city: Tours
country: France
facility: Hopital Bretonneau; Nephrologie Transplantations
city: Vannes
country: France
facility: Ch Bretagne Atlantique De Vannes; Nephrologie
city: Verdun
country: France
facility: Hopital Saint Nicolas; Medecine A
city: Villeurbanne
country: France
facility: Cabinet Medical
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: