Clinical trial NCT01974271: An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)
Official title: IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-01
Enrollment: 661
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months, previously treated with an erythropoietin stimulating agent (ESA) and for whom treatment with Mircera is indicated

Brief summary: This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
* Previously treated with an erythropoietin stimulating agent (ESA)
* Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
* Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL

Exclusion Criteria:

* Current participation in a clinical trial on renal anemia

Primary outcomes:
measure: Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of patients with Hb value within the range of 10 - 12 g/dL
timeFrame: 6 months
measure: Change in Hb level
timeFrame: from baseline to Month 6
measure: Monthly dose of Mircera
timeFrame: 6 months
measure: Safety: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Aix En Provence
country: France
city: Ajaccio
country: France
city: Annonay
country: France
city: Arras
country: France
city: Auch
country: France
city: Aurillac
country: France
city: Beauvais
country: France
city: Beauvais
country: France
city: Bois Bernard
country: France
city: Bordeaux
country: France
city: Bourg En Bresse
country: France
city: Bourgoin Jallieu
country: France
city: Brest
country: France
city: Chamalieres
country: France
city: Chaumont
country: France
city: Clermont Ferrand
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Condom
country: France
city: Dijon
country: France
city: Dourlers
country: France
city: Epinal
country: France
city: Fleurance
country: France
city: Fourmies
country: France
city: GAP
country: France
city: Gradignan
country: France
city: Haguenau
country: France
city: La Roche Sur Yon
country: France
city: La Tronche
country: France
city: Le Mans
country: France
city: Le Puy En Velay
country: France
city: Libourne
country: France
city: Lille
country: France
city: Maubeuge
country: France
city: Meaux
country: France
city: Mirande
country: France
city: Montereau
country: France
city: Nantes
country: France
city: Nantes
country: France
city: Neuilly Sur Seine
country: France
city: Nimes
country: France
city: Nogaro
country: France
city: Noyal Pontivy
country: France
city: Olivet
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Poitiers
country: France
city: Quimper
country: France
city: Quincy Sous Senart
country: France
city: Rambouillet
country: France
city: Rennes
country: France
city: Reze
country: France
city: Roubaix
country: France
city: Rouen
country: France
city: Saint Lo
country: France
city: Saint Marcel
country: France
city: Saint Nazaire
country: France
city: Saint Ouen
country: France
city: Salouel
country: France
city: Saran
country: France
city: St Brieuc
country: France
city: St Laurent Du Var
country: France
city: St Priest En Jarez
country: France
city: Stains
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vesoul
country: France
city: Villefranche de Rouergue
country: France
city: Yssingeaux
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: