A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01379963
First received: June 22, 2011
Last updated: March 16, 2012
Last verified: March 2012
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2011 | ||||
| Last Updated Date | March 16, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of patients achieving a 3-months hemoglobin level stabilization within the range of 11-12 g/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01379963 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Percentage of patients achieving a 6-months hemoglobin level stabilization within the range of 11-12 g/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) | ||||
| Official Title ICMJE | Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta) | ||||
| Brief Summary | This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with renal anemia on treatment with Mircera |
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| Condition ICMJE | Anemia, Kidney Disease, Chronic | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Cohort | ||||
| Publications * | Not Provided | ||||
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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 | 739 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (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 | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01379963 | ||||
| Other Study ID Numbers ICMJE | ML22014 | ||||
| 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 | March 2012 | ||||
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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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