A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
NCT ID: NCT00699348
Last Updated: 2016-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2008-07-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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C.E.R.A.
Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Interventions
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Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
* Regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months.
Exclusion Criteria
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* Active malignant disease (except non-melanoma skin cancer).
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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Acireale, , Italy
Ancona, , Italy
Anzio, , Italy
Arenzano, , Italy
Ascoli Piceno, , Italy
Avellino, , Italy
Benevento, , Italy
Bollate, , Italy
Borgomanero, , Italy
Brescia, , Italy
Brindisi, , Italy
Cagliari, , Italy
Castellammare di Stabia, , Italy
Catania, , Italy
Catania, , Italy
Cernusco sul Naviglio, , Italy
Chieri, , Italy
Chieti, , Italy
Civitavecchia, , Italy
Cosenza, , Italy
Ferrara, , Italy
Florence, , Italy
Florence, , Italy
Foggia, , Italy
Genova, , Italy
La Spezia, , Italy
Lecco, , Italy
Legnano, , Italy
Lido di Ostia, , Italy
Lodi, , Italy
Lucera, , Italy
Mantova, , Italy
Matera, , Italy
Milan, , Italy
Milazzo, , Italy
Montevarchi, , Italy
Napoli, , Italy
Napoli, , Italy
Nocera Inferiore, , Italy
Novara, , Italy
Nuoro, , Italy
Palermo, , Italy
Pavia, , Italy
Perugia, , Italy
Piacenza, , Italy
Pisa, , Italy
Ravenna, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
San Daniele del Friuli, , Italy
San Miniato, , Italy
Sassari, , Italy
Taranto, , Italy
Torino, , Italy
Udine, , Italy
Verona, , Italy
Vicenza, , Italy
Countries
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References
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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.
Locatelli F, Mandolfo S, Menegato Adorati M, Villa G, Tarchini R, Pizzarelli F, Conte F, Guastoni C, Ricciardi B, Crotta A. Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia. J Nephrol. 2013 Nov-Dec;26(6):1114-21. doi: 10.5301/jn.5000251. Epub 2013 Sep 13.
Other Identifiers
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2007-005799-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21438
Identifier Type: -
Identifier Source: org_study_id
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