A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis
2 other identifiers
interventional
127
1 country
69
Brief Summary
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2008
69 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
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 14, 2021
September 1, 2021
2.2 years
March 19, 2008
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
Weeks 16-24
Secondary Outcomes (4)
Mean change in Hb concentration
Between reference and Efficacy Evaluation Period
Mean time spent in Hb range
Weeks 16-24
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions
Weeks 16-48
AEs, lab parameters
Throughout study
Study Arms (1)
Methoxy Polyethylene Glycol-epoetin Beta
EXPERIMENTALParticipants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Interventions
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Eligibility Criteria
You may qualify if:
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
You may not qualify if:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Unknown Facility
Aix-en-Provence, 13090, France
Unknown Facility
Angers, 49000, France
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Angers, 49933, France
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Annonay, 07103, France
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Avignon, 84902, France
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Bastia, 20604, France
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Beauvais, 60000, France
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Besançon, 25030, France
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Bois-Guillaume, 76233, France
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Bordeaux, 33077, France
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Boulogne-sur-Mer, 62321, France
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Bourg-en-Bresse, 01012, France
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Bourges, 18020, France
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Brest, 29609, France
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Caen, 14033, France
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Chalon-sur-Saône, 71100, France
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Chartres, 28000, France
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Cherbourg Octeville, 50102, France
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Cholet, 49300, France
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Clermont-Ferrand, 63058, France
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Colmar, 68024, France
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Creil, 60100, France
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Créteil, 94010, France
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Dieppe, 76202, France
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Évreux, 27023, France
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Greize, 69400, France
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Harfleur, 76700, France
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La Garenne-Colombes, 92250, France
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La Tronche, 38701, France
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Le Havre, 76083, France
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Le Mans, 72037, France
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Lille, 59042, France
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Limoges, 87042, France
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Lyon, 69437, France
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Maubeuge, 59604, France
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Metz, 57045, France
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Metz-Tessy, 74370, France
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Montluçon, 03108, France
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Montpellier, 34097, France
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Montpellier, 34295, France
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Nancy, 54100, France
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Nice, 06002, France
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Nîmes, 30006, France
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Orléans, 45000, France
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Paris, 75018, France
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Paris, 75651, France
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Paris, 75743, France
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Paris, 75908, France
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Paris, 75970, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Quimper, 29000, France
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Roubaix, 59056, 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-Michel, 16470, France
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Saint-Nazaire, 44606, France
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Salouël, 80480, France
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Sens, 89108, France
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St-Malo, 35043, France
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Strasbourg, 67091, France
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Suresnes, 92151, France
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Thionville, 57126, France
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Toulouse, 31059, France
Unknown Facility
Tournan-en-Brie, 77220, France
Unknown Facility
Valenciennes, 59300, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Vannes, 56017, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 14, 2021
Record last verified: 2021-09