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Tracking Information | |||||
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First Received Date † | June 17, 2008 | ||||
Last Updated Date | May 13, 2009 | ||||
Start Date † | July 2008 | ||||
Current Primary Outcome Measures † |
Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00699348 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | CARISMA Study: A Study of Monthly 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 Hemodialysis 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 currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10-12g/dL. The anticipated time on study treatment is 1-2 years, 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 | ||||
Condition † | Anemia | ||||
Intervention † | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 300 | ||||
Estimated Completion Date | May 2010 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Italy | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00699348 | ||||
Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
Secondary IDs †† | 2007-005799-15 | ||||
Study Sponsor † | Hoffmann-La Roche | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Hoffmann-La Roche | ||||
Verification Date | May 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |