A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis
1 other identifier
interventional
421
1 country
89
Brief Summary
This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2008
Typical duration for phase_3
89 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
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 14, 2021
September 1, 2021
2.9 years
July 16, 2008
September 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
Weeks 16-24
Secondary Outcomes (2)
Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.
Weeks 16-24
Dose adjustments, RBC transfusions, AEs.
Throughout study
Study Arms (2)
Methoxy Polyethylene Glycol-epoetin Beta
EXPERIMENTALParticipants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
Epoetin Beta or Darbepoetin Alfa
ACTIVE COMPARATORParticipants who are receiving SC or IV epoetin beta or darbepoetin alfa will continue to receive the same treatment (epoetin beta or darbepoetin alfa at the same dose, same administration intervals, and the same route of administration). When necessary, dose adjustments will be performed according to Summary of Product Characteristics (SmPC). Total duration of treatment will be up to 48 weeks.
Interventions
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
Participants who are receiving SC or IV epoetin beta will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
Participants who are receiving SC or IV darbepoetin alfa will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
Eligibility Criteria
You may qualify if:
- regular long term hemodialysis with same schedule for greater than or equal to (\>=) 12 weeks
- continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose
You may not qualify if:
- transfusion of red blood cells during previous 2 months
- significant acute or chronic bleeding
- poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
- weekly dose of epoetin beta greater than (\>) 16000 international units (IU), or weekly dose of darbepoetin alfa \>80 micrograms during previous month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Unknown Facility
Abbeville, 80103, France
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Albi, 81030, France
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Amilly, 45200, France
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Angers, 49933, France
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Annonay, 07103, France
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Antony, 92166, France
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Aubagne, 13400, France
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Aulnay-sous-Bois, 93604, France
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Avignon, 84902, France
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Bagnols-sur-Cèze, 30200, France
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Beauvais, 60021, France
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Besançon, 25030, France
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Beuvry, 62660, France
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Béziers, 34525, France
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Bois-Bernard, 62320, France
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Bordeaux, 33077, France
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Brest, 29200, France
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Cabestany, 66330, France
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Caen, 14033, France
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Cannes, 06401, France
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Carpentras, 84200, France
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Castelnau-le-Lez, 34170, France
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Chamalières, 63400, France
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Charleville-Mézières, 08011, France
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Clermont-Ferrand, 63003, France
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Colmar, 68024, France
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Compiègne, 60200, France
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Creil, 60109, France
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Créteil, 94010, France
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Dijon, 21000, France
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Draguignan, 83300, France
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Évry, 91035, France
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Fleury-Mérogis, 91700, France
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Hyères, 83400, France
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La Chaussée-Saint-Victor, 41260, France
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La Rochelle, 17019, France
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La Tronche, 38701, France
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Le Mans, 72037, France
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Le Petit-Quevilly, 76143, France
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Le Port-Marly, 78560, France
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Lille, 59037, France
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Lille, 59042, France
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Lliie, 59003, France
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Lyon, 69008, France
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Manosque, 04100, France
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Marseille, 13008, France
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Marseille, 13253, France
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Meaux, 77104, France
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Metz, 57003, France
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Montpellier, 34295, France
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Mulhouse, 68070, France
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Muret, 31600, France
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Nantes, 44035, France
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Orléans, 45000, France
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Paris, 75 016, France
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Paris, 75008, France
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Paris, 75013, France
Unknown Facility
Paris, 75015, France
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Paris, 75651, France
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Paris, 75674, France
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Paris, 75970, France
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Perpignan, 66046, France
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Pessac, 33608, France
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Pierre-Bénite, 69495, France
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Poissy, 78303, France
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Poitiers, 86021, France
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Quincy-sous-Sénart, 91480, France
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Reims, 51092, France
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Rouen, 76040, France
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Rueil-Malmaison, 92500, France
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Saint-Benoît, 97470, France
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Saint-Brieuc, 22027, France
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Saint-Denis, 97405, France
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Saint-Maurice, 94415, France
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Saint-Ouen, 93400, France
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Saint-Pierre-des-Corps, 97448, France
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Saint-Priest-en-Jarez, 42277, France
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Saint-Quentin, 02100, France
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Saintes, 17108, France
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Strasbourg, 67200, France
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Tassin-la-Demi-Lune, 69150, France
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Toulon, 83056, France
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Toulouse, 31059, France
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Toulouse, 31077, France
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Trappes, 78190, France
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Vandœuvre-lès-Nancy, 54511, France
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Vannes, 56017, France
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Vienne, 38209, France
Unknown Facility
Villeurbanne, 69626, France
Related Publications (2)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVEDLocatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
PMID: 26965694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 14, 2021
Record last verified: 2021-09