A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
NCT ID: NCT00717821
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2008-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Methoxy Polyethylene Glycol-epoetin Beta
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.
Methoxy Polyethylene Glycol-epoetin Beta
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.
Epoetin Beta or Darbepoetin Alfa
Participants 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.
Epoetin Beta
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.
Darbepoetin Alfa
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.
Interventions
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Methoxy Polyethylene Glycol-epoetin Beta
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.
Epoetin Beta
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.
Darbepoetin Alfa
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Abbeville, , France
Albi, , France
Amilly, , France
Angers, , France
Annonay, , France
Antony, , France
Aubagne, , France
Aulnay-sous-Bois, , France
Avignon, , France
Bagnols-sur-Cèze, , France
Beauvais, , France
Besançon, , France
Beuvry, , France
Béziers, , France
Bois-Bernard, , France
Bordeaux, , France
Brest, , France
Cabestany, , France
Caen, , France
Cannes, , France
Carpentras, , France
Castelnau-le-Lez, , France
Chamalières, , France
Charleville-Mézières, , France
Clermont-Ferrand, , France
Colmar, , France
Compiègne, , France
Creil, , France
Créteil, , France
Dijon, , France
Draguignan, , France
Évry, , France
Fleury-Mérogis, , France
Hyères, , France
La Chaussée-Saint-Victor, , France
La Rochelle, , France
La Tronche, , France
Le Mans, , France
Le Petit-Quevilly, , France
Le Port-Marly, , France
Lille, , France
Lille, , France
Lliie, , France
Lyon, , France
Manosque, , France
Marseille, , France
Marseille, , France
Meaux, , France
Metz, , France
Montpellier, , France
Mulhouse, , France
Muret, , France
Nantes, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Perpignan, , France
Pessac, , France
Pierre-Bénite, , France
Poissy, , France
Poitiers, , France
Quincy-sous-Sénart, , France
Reims, , France
Rouen, , France
Rueil-Malmaison, , France
Saint-Benoît, , France
Saint-Brieuc, , France
Saint-Denis, , France
Saint-Maurice, , France
Saint-Ouen, , France
Saint-Pierre-des-Corps, , France
Saint-Priest-en-Jarez, , France
Saint-Quentin, , France
Saintes, , France
Strasbourg, , France
Tassin-la-Demi-Lune, , France
Toulon, , France
Toulouse, , France
Toulouse, , France
Trappes, , France
Vandœuvre-lès-Nancy, , France
Vannes, , France
Vienne, , France
Villeurbanne, , France
Countries
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References
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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.
Locatelli 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.
Other Identifiers
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ML21145
Identifier Type: -
Identifier Source: org_study_id
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