An Observational Study of Patients' Perception of Treatment With Erythropoiesis-Stimulating Agents in Patients With Chronic Kidney Disease Not on Dialysis (PERCEPOLIS)
1 other identifier
observational
815
1 country
109
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedNovember 3, 2015
November 1, 2015
1.1 years
January 21, 2014
November 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Relative importance for patients of different attributes of ESA treatment, assessed by Choice Based Conjoint questionnaire at baseline and Month 6
6 months
Secondary Outcomes (7)
Biological parameters: hemoglobin concentration at each observation time point.
6 months
Adherence to Mircera treatment assessed by a questionnaire adapted from the Morisky scale at baseline and at Month 6
6 months
Dose/schedule of Mircera treatment at each observation timepoint
6 months
Concomitant medication/treatments in the management of anemia
6 months
Proportion of patients with a hemoglobin level between 10 and 12 g/dL after 6 months of treatment with Mircera
Month 6
- +2 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
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
You may qualify if:
- 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
- Accepting and able of completing the ESA preference questionnaire
You may not qualify if:
- Participation in a clinical trial on anemia
- Dialysis planned in the next 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Unknown Facility
Aix-en-Provence, 13100, France
Unknown Facility
Ajaccio, 20303, France
Unknown Facility
Annonay, 07103, France
Unknown Facility
Arras, 62022, France
Unknown Facility
Avignon, 84000, France
Unknown Facility
Bagnols-sur-Cèze, 30200, France
Unknown Facility
Bayonne, 64109, France
Unknown Facility
Beauvais, 60021, France
Unknown Facility
Belley, 01300, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Bièvres, 91570, France
Unknown Facility
Bois-Guillaume, 76233, France
Unknown Facility
Bordeaux, 33077, France
Unknown Facility
Bourg-en-Bresse, 01012, France
Unknown Facility
Bourgoin, 38317, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Cabestany, 66330, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Castelnau-le-Lez, 34170, France
Unknown Facility
Chalon-sur-Saône, 71100, France
Unknown Facility
Champigny-sur-Marne, 94507, France
Unknown Facility
Charleville-Mézières, 08011, France
Unknown Facility
Chaumont, 52001, France
Unknown Facility
Châteauroux, 36000, France
Unknown Facility
Clermont-Ferrand, 63003, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Creil, 60109, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Dijon, 21000, France
Unknown Facility
Dijon, 21079, France
Unknown Facility
Dole, 39108, France
Unknown Facility
Draguignan, 83300, France
Unknown Facility
Épinal, 88021, France
Unknown Facility
Évian-les-Bains, 74500, France
Unknown Facility
Évreux, 27023, France
Unknown Facility
Freyming-Merlebach, 57804, France
Unknown Facility
Gap, 05000, France
Unknown Facility
Gradignan, 33171, France
Unknown Facility
Greize, 69400, France
Unknown Facility
Grenoble, 38028, France
Unknown Facility
Haguenau, 67504, France
Unknown Facility
La Chaussée-Saint-Victor, 41260, France
Unknown Facility
La Roche-sur-Yon, 85925, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
La Tronche, 38701, France
Unknown Facility
Laon, 02001, France
Unknown Facility
Le Mans, 72037, France
Unknown Facility
Le Mans, 72100, France
Unknown Facility
Le Puy-en-Velay, 43012, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Lille, 59042, France
Unknown Facility
Lorient, 56322, France
Unknown Facility
Lyon, 69008, France
Unknown Facility
Marseille, 13253, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Maubeuge, 59607, France
Unknown Facility
Mâcon, 71018, France
Unknown Facility
Melun, 77011, France
Unknown Facility
Metz, 57003, France
Unknown Facility
Mont-de-Marsan, 40024, France
Unknown Facility
Mont-Saint-Martin, 54350, France
Unknown Facility
Montluçon, 03108, France
Unknown Facility
Mullhouse, 68100, France
Unknown Facility
Nancy, 54100, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nantes, 44202, France
Unknown Facility
Nice, 06002, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Olivet, 45160, France
Unknown Facility
Ollioules, 83190, France
Unknown Facility
Orléans, 45000, France
Unknown Facility
Orléans, 45100, France
Unknown Facility
Paris, 75008, France
Unknown Facility
Paris, 75011, France
Unknown Facility
Paris, 75014, France
Unknown Facility
Paris, 75230, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75877, France
Unknown Facility
Paris, 75908, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Poissy, 78303, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Quimper, 29000, France
Unknown Facility
Quimper, 29107, France
Unknown Facility
Rambouillet, 78514, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Roanne, 42328, France
Unknown Facility
Rodez, 12027, France
Unknown Facility
Romans-sur-Isère, 26102, France
Unknown Facility
Rouen, 76040, France
Unknown Facility
Saint-Laurent-du-Var, 06700, France
Unknown Facility
Saint-Laurent-du-Var, 06721, France
Unknown Facility
Saint-Lô, 50009, France
Unknown Facility
Saint-Priest-en-Jarez, 42277, France
Unknown Facility
Saint-Quentin, 02321, France
Unknown Facility
Salouël, 80480, France
Unknown Facility
Sens, 89100, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Toulon, 83056, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tournan-en-Brie, 77220, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Valenciennes, 59322, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Vannes, 56017, France
Unknown Facility
Vesoul, 70014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 23, 2014
Study Start
May 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
November 3, 2015
Record last verified: 2015-11