Clinical trial NCT02042833: An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 815
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: Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation), initiating treatment with Mircera, and erythropoiesis-stimulating agent (ESA)-naïve or not

Brief summary: This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with chronic kidney disease not on dialysis (with or without previous renal transplantation)
* Treated or not with ESA at time of visit
* Patients for whom the treating physician had decided to initiate Mircera for medical reasons before the commencement of the study
* Initiation of treatment with Mircera at the inclusion visit
* Accepting and able of completing the ESA preference questionnaire

Exclusion Criteria:

* Participation in a clinical trial on anemia
* Treatment with Mircera during the 3 months before inclusion
* Dialysis planned in the next 6 months

Primary outcomes:
measure: Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6
timeFrame: 6 months
Secondary outcomes:
measure: Biological parameters: hemoglobin concentration at each observation time point.
timeFrame: 6 months
measure: Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6
timeFrame: 6 months
measure: Dose/schedule of Mircera treatment at each observation timepoint
timeFrame: 6 months
measure: Concomitant medication/treatments in the management of anemia
timeFrame: 6 months
measure: Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera
timeFrame: Month 6
measure: Change in hemoglobin level
timeFrame: from baseline to Month 6
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: Avignon
country: France
city: Bagnols Sur Ceze
country: France
city: Bayonne
country: France
city: Beauvais
country: France
city: Belley
country: France
city: Besancon
country: France
city: Bievres
country: France
city: Bois Guillaume
country: France
city: Bordeaux
country: France
city: Bourg En Bresse
country: France
city: Bourgoin Jallieu
country: France
city: Brest
country: France
city: Cabestany
country: France
city: Caen
country: France
city: Castelnau le Lez
country: France
city: Chalon Sur Saone
country: France
city: Champigny Sur Marne
country: France
city: Charleville Mezieres
country: France
city: Chateauroux
country: France
city: Chaumont
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Creil
country: France
city: Creteil
country: France
city: Dijon
country: France
city: Dijon
country: France
city: Dole
country: France
city: Draguignan
country: France
city: Epinal
country: France
city: Evian Les Bains
country: France
city: Evreux
country: France
city: Freyming Merlebach
country: France
city: GAP
country: France
city: Gradignan
country: France
city: Greize
country: France
city: Grenoble
country: France
city: Haguenau
country: France
city: La Chaussee St Victor
country: France
city: La Roche Sur Yon
country: France
city: La Tronche
country: France
city: La Tronche
country: France
city: Laon
country: France
city: Le Mans
country: France
city: Le Mans
country: France
city: Le Puy En Velay
country: France
city: Lille
country: France
city: Lille
country: France
city: Lorient
country: France
city: Lyon
country: France
city: Macon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Maubeuge
country: France
city: Melun
country: France
city: Metz
country: France
city: Mont De Marsan
country: France
city: Mont St Martin
country: France
city: Montlucon
country: France
city: Mullhouse
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nimes
country: France
city: Olivet
country: France
city: Ollioules
country: France
city: Orleans
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Poissy
country: France
city: Poitiers
country: France
city: Quimper
country: France
city: Quimper
country: France
city: Rambouillet
country: France
city: Rennes
country: France
city: Roanne
country: France
city: Rodez
country: France
city: Romans Sur Isere
country: France
city: Rouen
country: France
city: Saint Laurent Du Var
country: France
city: Saint Lo
country: France
city: Salouel
country: France
city: Sens
country: France
city: St Laurent Du Var
country: France
city: St Laurent Du Var
country: France
city: St Priest En Jarez
country: France
city: St Quentin
country: France
city: Strasbourg
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Tournan-en-brie
country: France
city: Tours
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Vesoul
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: