An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)
IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A
1 other identifier
observational
661
1 country
76
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 2, 2016
November 1, 2016
1.2 years
October 28, 2013
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
6 months
Secondary Outcomes (4)
Percentage of patients with Hb value within the range of 10 - 12 g/dL
6 months
Change in Hb level
from baseline to Month 6
Monthly dose of Mircera
6 months
Safety: Incidence of adverse events
6 months
Study Arms (1)
Cohort
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Current participation in a clinical trial on renal anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Ajaccio, 20303, France
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Annonay, 07100, France
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Arras, 62022, France
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Auch, 32008, France
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Aurillac, 15013, France
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Beauvais, 60000, France
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Beauvais, 60021, France
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Bois-Bernard, 62320, France
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Bordeaux, 33000, France
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Bourg-en-Bresse, 01012, France
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Bourgoin, 38317, France
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Brest, 29609, France
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Chamalières, 63400, France
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Chaumont, 52001, France
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Clermont-Ferrand, 63003, France
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Clermont-Ferrand, 63050, France
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Colmar, 68024, France
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Condom, 32100, France
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Dijon, 21000, France
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Dourlers, 59440, France
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Épinal, 88021, France
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Fleurance, 32500, France
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Fourmies, 59611, France
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Gap, 05000, France
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Gradignan, 33171, France
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Haguenau, 67504, France
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La Roche-sur-Yon, 85925, France
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La Tronche, 38701, France
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Le Mans, 72037, France
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Le Puy-en-Velay, 43012, France
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Libourne, 33505, France
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Lille, 59042, France
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Maubeuge, 59607, France
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Meaux, 77104, France
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Mirande, 32300, France
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Montereau, 77871, France
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Nantes, 44035, France
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Nantes, 44093, France
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Neuilly-sur-Seine, 92523, France
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Nîmes, 30900, France
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Nogaro, 32110, France
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Noyal-Pontivy, 56920, France
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Olivet, 45160, France
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Orléans, 45100, France
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Paris, 75 016, France
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Paris, 75009, France
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Paris, 75014, France
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Paris, 75970, France
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Pessac, 33608, France
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Poitiers, 86021, France
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Quimper, 29107, France
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Quincy-sous-Sénart, 91480, France
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Rambouillet, 78514, France
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Rennes, 35033, France
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Rezé, 44402, France
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Roubaix, 59100, France
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Rouen, 76040, France
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Saint-Brieuc, 22027, France
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Saint-Laurent-du-Var, 06721, France
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Saint-Lô, 50009, France
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Saint-Marcel, 27950, France
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Saint-Nazaire, 63050, France
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Saint-Ouen, 93400, France
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Saint-Priest-en-Jarez, 42277, France
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Salouël, 80480, France
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Saran, 45770, France
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Stains, 93240, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Tourcoing, 59200, France
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Valenciennes, 59300, France
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Vandœuvre-lès-Nancy, 54511, France
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Vesoul, 70014, France
Unknown Facility
Villefranche-de-Rouergue, 12200, France
Unknown Facility
Yssingeaux, 43200, 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
October 28, 2013
First Posted
November 1, 2013
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11