An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
First received: January 15, 2010
Last updated: November 17, 2015
Last verified: November 2015
Results First Received: November 17, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Anemia
Intervention: Drug: methoxy polyethylene glycol-ep [Mircera]

  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
Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.

Reporting Groups
  Description
Methoxy Polyethylene Glycol-epoetin Beta (All Participants) Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.

Participant Flow:   Overall Study
    Methoxy Polyethylene Glycol-epoetin Beta (All Participants)  
STARTED     1580  
Received at Least One Dose     1547  
COMPLETED     1041  
NOT COMPLETED     539  
Discontinuation of treatment                 103  
Transplantation                 28  
Dialysis dependency                 22  
Withdrawal by Subject                 13  
Lost to Follow-up                 31  
Death                 129  
Hospitalization                 28  
Unspecified                 148  
Missing                 37  



  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.
Full Analysis Set (FAS): all participants for whom at least one hemoglobin value after the first application of methoxy polyethylene glycol-epoetin beta during the study course was documented.

Reporting Groups
  Description
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Total Total of all reporting groups

Baseline Measures
    Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)     Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)     Total  
Number of Participants  
[units: participants]
  326     1184     1510  
Age  
[units: years]
Mean (Standard Deviation)
  71.8  (13.3)     68.0  (13.8)     68.8  (13.8)  
Gender  
[units: participants]
     
Female     158     479     637  
Male     168     705     873  



  Outcome Measures
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1.  Primary:   Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range   [ Time Frame: Month 0 to Month 12 ]

2.  Primary:   Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size   [ Time Frame: Month 0 to Month 12 ]

3.  Primary:   Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size   [ Time Frame: Month 6 to Month 12 ]

4.  Primary:   Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size   [ Time Frame: Month 0 to Month 12 ]

5.  Primary:   Serum Ferritin Values   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]

6.  Primary:   Serum Iron Values   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]

7.  Primary:   Transferrin Values   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]

8.  Primary:   Transferrin Saturation Values   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]

9.  Primary:   C-reactive Protein (CRP) Values   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]

10.  Primary:   Number of Physicians Satisfied With Treatment at Final Visit   [ Time Frame: Month 12 or early discontinuation ]

11.  Primary:   Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion   [ Time Frame: Month 12 or early discontinuation ]

12.  Primary:   Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion   [ Time Frame: Month 12 or early discontinuation ]

13.  Primary:   Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy   [ Time Frame: Month 12 or early discontinuation ]

14.  Primary:   Number of Participants Satisfied With Treatment at Final Visit   [ Time Frame: Month 12 or early discontinuation ]

15.  Secondary:   Average Methoxy Polyethylene Glycol-epoetin Beta Dose   [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ]


  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: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01051323     History of Changes
Other Study ID Numbers: ML22714
Study First Received: January 15, 2010
Results First Received: November 17, 2015
Last Updated: November 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices