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Tracking Information | |||||
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First Received Date † | October 16, 2007 | ||||
Last Updated Date | April 15, 2009 | ||||
Start Date † | October 2007 | ||||
Current Primary Outcome Measures † |
Percentage of patients maintaining average Hb concentration within country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria) OR +/- 1g/dL of reference Hb concentration during evaluation period. [ 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 NCT00545571 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
Efficacy: Change in Hb conc between reference and EEP; mean time spent in country-specific target range; % pts. maintaining Hb within country-specific target range;dose adjustments; RBC transfusions. Safety: AEs, lab parameters, vital signs. | ||||
Descriptive Information | |||||
Brief Title † | MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia. | ||||
Official Title † | A Single Arm, Open Label, Interventional Multicenter Study to 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. | ||||
Brief Summary | This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darbepoetin alfa, epoetin alfa or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120 or 200 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria). 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 † | 200 | ||||
Estimated Completion Date | December 2009 | ||||
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 † | Austria, Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00545571 | ||||
Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
Secondary IDs †† | |||||
Study Sponsor † | Hoffmann-La Roche | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Hoffmann-La Roche | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |