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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01379963
First received: June 22, 2011
Last updated: November 20, 2015
Last verified: November 2015
Results First Received: November 20, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Anemia, Kidney Disease, Chronic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Methoxy-Polyethylene-Glycol-Epoetin Beta Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.

Participant Flow:   Overall Study
    Methoxy-Polyethylene-Glycol-Epoetin Beta  
STARTED     780  
COMPLETED     780  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline population included all enrolled participants.

Reporting Groups
  Description
Methoxy-Polyethylene-Glycol-Epoetin Beta Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.

Baseline Measures
    Methoxy-Polyethylene-Glycol-Epoetin Beta  
Number of Participants  
[units: participants]
  780  
Age [1]
[units: Years]
Mean (Standard Deviation)
  68.64  (14.10)  
Gender, Customized  
[units: Participants]
 
Female     442  
Male     325  
Missing     13  
[1] Here, 773 participants were analyzed for this baseline measure (age). Since this is a non-interventional retrospective study participants with missing data were excluded from the analysis.



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)   [ Time Frame: Up to 6 months ]

2.  Secondary:   Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL   [ Time Frame: Up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann­LaRoche
phone: 800­821­8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01379963     History of Changes
Other Study ID Numbers: ML22014
Study First Received: June 22, 2011
Results First Received: November 20, 2015
Last Updated: November 20, 2015
Health Authority: Greece: National Organization for Medicines