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)

Renal Anemia of Chronic Kidney Disease Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756612
• Other study ID #: ML28145
• Status: Completed
• Start date: November 21, 2012
• Est. completion date: March 25, 2015

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: March 25, 2015
• Est. primary completion date: March 25, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Anemia of Chronic Kidney Disease
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	CHP Aix	Aix En Provence
France	Ch Notre Dame Misericorde; Hemodialyse	Ajaccio
France	Chi D Alencon;Nephrologie Hemodialyse	Alencon
France	Centre Aider	Ales
France	Hotel Dieu; Nephrologie Hemodialyse	Angers
France	Centre Hospitalier; Hemodialyse	Annonay
France	Centre Hemodialyse La Riviera	Antibes
France	Ch D Arras; Nephrologie	Arras
France	Chp Aubagne	Aubagne
France	Ch Henri Duffaut; Nephrologie Hemodialyse	Avignon
France	Chic Cote Basque Bayonne; Nephrologie Hemodialyse	Bayonne
France	Ch De Beauvais; Neph Endocrino Dialyse Diabeto	Beauvais
France	Centre D Hemodialyse Regina	Belley
France	CHU Saint Jacques; Centre De Dialyse	Besancon
France	Ch Germon Et Gauthier; Medecine Interne Nephrologie	Beuvry
France	CNB - Centre Nephrologie Du Biterrois	Beziers
France	Cabinet Medical	Bordeaux
France	Centre Hemodialyse St Augustin; Nephrologie	Bordeaux
France	Hopital Pellegrin; Departement Nephrologie	Bordeaux
France	Ch De Fleyriat; Nephrologie Hemodialyse	Bourg En Bresse
France	Aural; Service Hemodialyse	Bourgoin Jallieu
France	Hopital La Cavale Blanche; Nephrologie	Brest
France	Ch de Brive la Gaillarde; Nephrologie Hemodialyse	Brive La Gaillarde
France	Centre D Hemodialyse Saint Roch	Cabestany
France	Hopital Clemenceau; Nephrologie Hemodialyse	Caen
France	Ch Antoine Gayraud; Nephrologie Hemodialyse	Carcassonne
France	Centre Hemodialyse Du Lez; Nephrologie	Castelnau le Lez
France	CH William Morey; Nephrologie	Chalon Sur Saone
France	Aura Auvergne; Aura Auvergne	Chamalieres
France	Ch De Chambery; Nephrologie	Chambery
France	Avitum France; Centre De Nephrologie	Chateauroux
France	Centre Hospitalier; Hemodialyse	Cholet
France	Centre De Sante Medical; Centre De Sante Republique	Clermont Ferrand
France	Hopital Gabriel Montpied	Clermont-ferrand
France	Ch Laennec; Nephrologie Hemodialyse	Creil
France	Fondation Transplantation; Ctirc De Drevon	Dijon
France	Nephrocare Ile De France; Etampes	Etampes
France	Chi Eure Seine D Evreux; Nephrologie	Evreux
France	Cabinet Medical	Fontaine Les Dijon
France	Hopital De Freyming; Nephrologie	Freyming Merlebach
France	Centre Hospitalier General; Service de Nephrologie-Hemodialyse	GAP
France	Association Aurad Aquitaine; Aurad Gradignan	Gradignan
France	Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse	Greize
France	Ch Dptal Les Oudairies; Nephrologie	La Roche Sur Yon
France	Agduc Muller	La Tronche
France	Hopital Albert Michallon; Clinique De Nephrologie	La Tronche
France	Ch De Laon; Nephrologie Hemodialyse	Laon
France	Hopital Prive De L Estuaire; Nephrologie Hemodialyse	Le Havre
France	Ch Emile Roux; Nephrologie	Le Puy En Velay
France	Hopital Claude Huriez; Nephrologie	Lille
France	Polyclinique De La Louviere; Nephrologie	Lille
France	Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse	Lyon
France	Hopital Edouard-Herriot; Nephrologie - Hemodialyse	Lyon
France	Clinique Bouchard ; Nephrologie	Marseille
France	Hopital De La Conception; Hemodialyse	Marseille
France	Hopital De La Conception; Nephrologie	Marseille
France	Ch De Meaux; Medecine C	Meaux
France	Hopital Layne; Nephrologie Hemodialyse	Mont De Marsan
France	Hopital Hotel Dieu; Medecine Geriatrique Nephrologie	Mont St Martin
France	Centre D Hemodialyse Sodetir	Montereau
France	Centre Aider; Centre Aider Montpellier	Montpellier
France	Centre De Dialyse La Fonderie	Mullhouse
France	Polyclinique De Gentilly; Hemodialyse	Nancy
France	Echo Nantes Confluent; Uad Montfort	Nantes
France	Hopital Hotel Dieu Et Hme; Hemodialyse Chronique	Nantes
France	Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique	Nantes
France	Hopital Pasteur; Pavillon A Nephrologie	Nice
France	Centre Gardialyse	Nimes
France	Ctre Dialyse De La Reine Blanche	Orleans
France	Hopital de La Source; Service de Nephrologie & Hemodialyse	Orleans
France	Ch Pitie Salpetriere; Nephrologie Hemodialyse	Paris
France	Hopital Europeen Georges Pompidou; Service de Nephrologie	Paris
France	Hopital Saint Louis; Service de Nephrologie - Transplantation	Paris
France	Hopital Tenon; Nephrologie Dialyse	Paris
France	Hopital Saint Jean; Nephrologie	Perpignan
France	Centre Hemodialyse Saint Martin	Pessac
France	Ch Lyon Sud; Nephrologie Sect Jules Courmont	Pierre Benite
France	Chi Poissy Saint Germain En Laye; Hemodialyse	Poissy
France	Chu La Miletrie;Nephrologie Transplantation	Poitiers
France	Association Pour L'Aide Des Uremiques de Bretagne	Quimper
France	Hopital Pontchaillou; Nephrologie	Rennes
France	Clinique De L Europe; Hemodialyse	Rouen
France	Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse	Saint Laurent Du Var
France	Memorial France Etats Unis; Nephrologie	Saint Lo
France	Hopital Broussais; Medecine 4	Saint-malo
France	Nephrocare Tassin Charcot; Nephrologie	Sainte Foy les Lyon
France	Hopital Sud ; Nephrologie Hemodialyse	Salouel
France	Centre Hospitalier De Sens; Nephrologie-Dialyse	Sens
France	Ch Gaston Ramon; Nephrologie	Sens
France	Ch De Soissons; Medecine 5	Soissons
France	Chi Du Val D Ariege; Gastro Enterologie Nephrologie	St Jean De Verges
France	Centre D Hemodialyse	St Laurent Du Var
France	Institut Arnault Tzanck; Med 2	St Laurent Du Var
France	Artic; Bureau	St Priest En Jarez
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	Nephrocare Ile de France; Suresnes	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	Hopital Rangueil; Nephrologie Hemodialyse	Toulouse
France	Clinique de Tournan; Service de Nephrologie	Tournan-en-brie
France	Hopital Bretonneau; Nephrologie Transplantations	Tours
France	Ch Bretagne Atlantique De Vannes; Nephrologie	Vannes
France	Hopital Saint Nicolas; Medecine A	Verdun
France	Cabinet Medical	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Average Dose of Mircera in Total Population		Baseline up to 9 months
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population		Baseline up to 9 months
Secondary	Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation		Baseline up to 9 months
Secondary	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
Secondary	Duration of Treatment With Mircera		Baseline up to 9 months
Secondary	Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia		Baseline up to 9 month