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A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01356589
First received: May 18, 2011
Last updated: November 23, 2015
Last verified: November 2015
Results First Received: November 23, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Anemia

  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
Mircera Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.

Participant Flow:   Overall Study
    Mircera  
STARTED     1288  
Treated     1285  
COMPLETED     1283  
NOT COMPLETED     5  
Enrolled, but not treated                 3  
Dose data not recorded                 2  



  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.
Analysis population included all treated participants.

Reporting Groups
  Description
Mircera Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.

Baseline Measures
    Mircera  
Number of Participants  
[units: participants]
  1285  
Age [1]
[units: years]
Mean (Standard Deviation)
  70.13  (13.75)  
Gender  
[units: participants]
 
Female     570  
Male     715  
[1] Data for this baseline characteristic were available for 1276 participants only.



  Outcome Measures
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1.  Primary:   Percentage of Participants With at Least One Hemoglobin Cycling   [ Time Frame: 9 months ]

2.  Secondary:   Number of Full Hemoglobin Cycles Per Participant   [ Time Frame: 9 months ]

3.  Secondary:   Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling   [ Time Frame: 9 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: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356589     History of Changes
Other Study ID Numbers: ML25289
Study First Received: May 18, 2011
Results First Received: November 23, 2015
Last Updated: November 23, 2015
Health Authority: Greece: National Organization of Medicines