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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677767
First received: August 30, 2012
Last updated: February 8, 2016
Last verified: February 2016
Results First Received: January 6, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
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
A total of 127 participants were enrolled from 7 centers in India. This study was conducted between 14 April 2011 and 23 September 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 127 participants enrolled in the study, 1 participant was enrolled wrongly and data for 2 participants were not available at the study Centre. Therefore, 124 participants were evaluated in this study.

Reporting Groups
  Description
C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.

Participant Flow:   Overall Study
    C.E.R.A.  
STARTED     124  
COMPLETED     102  
NOT COMPLETED     22  
Adverse Event                 1  
Death                 4  
Protocol Violation                 4  
Withdrawal by Subject                 10  
Non-compliance by the participants                 3  



  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.
Intention-to-Treat (ITT) population included all the participants who received at least 1 dose of C.E.R.A and for whom data for at least one follow-up variable was available

Reporting Groups
  Description
C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.

Baseline Measures
    C.E.R.A.  
Number of Participants  
[units: participants]
  124  
Age  
[units: Years]
Mean (Standard Deviation)
  48.1  (12.26)  
Gender  
[units: Participants]
 
Female     41  
Male     83  
Height [1]
[units: Centimeters]
Mean (Standard Deviation)
  157.83  (10.056)  
[1] For mean height of participants n = 112 as height of some participants was not captured.



  Outcome Measures
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1.  Primary:   Mean Age of Participants Treated With C.E.R.A   [ Time Frame: Baseline (Week 0) ]

2.  Primary:   Mean Weight of Participants Treated With C.E.R.A   [ Time Frame: Baseline (Week 0) ]

3.  Primary:   Number of Participants With Co-morbidity Treated With C.E.R.A   [ Time Frame: Up to Week 24 ]

4.  Primary:   Mean Time Required to Achieve Target Hemoglobin Range   [ Time Frame: Up to Week 24 ]

5.  Primary:   Percentage of Participants Achieved Target Range of Hemoglobin   [ Time Frame: Up to Week 24 ]

6.  Primary:   Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.   [ Time Frame: Up to Week 24 ]

7.  Secondary:   Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study   [ Time Frame: Up to Week 24 ]

8.  Secondary:   Mean Time Spent by Participants in the Hb Target Range   [ Time Frame: Up to Week 24 ]

9.  Secondary:   Evaluation of Route of Administration for C.E.R.A   [ Time Frame: Up to Week 24 ]

10.  Secondary:   Evaluation of Dose Per Injection of C.E.R.A   [ Time Frame: Up to Week 24 ]

11.  Secondary:   Number of Participants Received Concomitant Medications   [ Time Frame: Up to Week 24 ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01677767     History of Changes
Other Study ID Numbers: ML25475
Study First Received: August 30, 2012
Results First Received: January 6, 2016
Last Updated: February 8, 2016
Health Authority: India: Drug Controller General