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| Descriptive Information Fields | |||||||||
| Brief Title † | A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia | ||||||||
| Official Title † | A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia. | ||||||||
| Brief Summary | This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | % patients maintaining mean Hb conc. within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Change in mean Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ] % patients maintaining Hb within target range [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ] % patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ] AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ] |
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| Condition † | Anemia | ||||||||
| Intervention † | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Start Date † | May 2008 | ||||||||
| Completion Date | June 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Turkey | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00661505 | ||||||||
| Organization ID | ML21096 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Hoffmann-La Roche | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Hoffmann-La Roche | ||||||||
| Verification Date | December 2008 | ||||||||
| First Received Date † | April 16, 2008 | ||||||||
| Last Updated Date | December 2, 2008 | ||||||||
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