A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413894
First received: December 19, 2006
Last updated: October 18, 2011
Last verified: October 2011
| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2006 | ||||
| Last Updated Date | October 18, 2011 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Percentage of patients in a defined Hb range during evaluation period; percentage of patients with or without dose adjustments during evaluation period. | ||||
| Change History | Complete list of historical versions of study NCT00413894 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Efficacy: percentage of patients in a defined range, and with or without dose adjustments, during screening period; incidence of RBC transfusions. Safety: AEs, lab parameters, vital signs. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients. | ||||
| Official Title ICMJE | An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment. | ||||
| Brief Summary | This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Anemia | ||||
| Intervention ICMJE | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
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| Publications * | Fliser D, Kleophas W, Dellana F, Winkler RE, Backs W, Kraatz U, Fassbinder W, Wizemann V, Strack G. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010 May;26(5):1083-9. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 661 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| 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 | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00413894 | ||||
| Other Study ID Numbers ICMJE | ML20572 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | October 2011 | ||||
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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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