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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 18, 2007 | ||||
| Last Updated Date | November 17, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change in Hb concentration between screening and evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Change in Hb concentration between screening and evaluation period. | ||||
| Change History | Complete list of historical versions of study NCT00576628 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Efficacy: Percentage of patients maintaining average Hb conc. of 11.0-13.0g/dL throughout evaluation period; mean time spent in target Hb range; mean no. of months/subject requiring any dose adjustment; RBC transfusions. Safety: AEs, lab parameters. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients. | ||||
| Official Title ICMJE | An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA. | ||||
| Brief Summary | This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Anemia | ||||
| Intervention ICMJE | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* 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 ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Russian Federation | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00576628 | ||||
| Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | ML20978 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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