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A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413894
First received: December 19, 2006
Last updated: January 17, 2016
Last verified: January 2016
Results First Received: January 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 661 participants with renal anemia due to chronic kidney disease (CKD) were enrolled; of which, 424 participants were treated with methoxy polyethylene glycol-epoetin beta (C.E.R.A) and are included in results.

Reporting Groups
  Description
Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A) During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant’s hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.

Participant Flow:   Overall Study
    Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)
STARTED   424 
COMPLETED   344 
NOT COMPLETED   80 
Withdrawal by Subject                10 
Administrative Reasons                1 
Hb <10 grams/deciliter                12 
Adverse Event                28 
Protocol Violation                11 
Unspecified                18 



  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.
Safety Population included all participants who received at least one dose of study medication independent of whether they completed the study or not.

Reporting Groups
  Description
C.E.R.A During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.

Baseline Measures
   C.E.R.A 
Overall Participants Analyzed 
[Units: Participants]
 424 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (14.7) 
Gender 
[Units: Participants]
 
Female   166 
Male   258 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase   [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]

2.  Primary:   Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase   [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]

3.  Primary:   Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase   [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]

4.  Primary:   Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase   [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]

5.  Secondary:   Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase   [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]

6.  Secondary:   Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase   [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]

7.  Secondary:   Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase   [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]

8.  Secondary:   Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase   [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]

9.  Secondary:   Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels   [ Time Frame: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8) ]

10.  Secondary:   Percentage of Participants With Hb Fluctuations Within Evaluation Phase   [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]

11.  Secondary:   Percentage of Participants With Hb Fluctuations Within Screening Phase   [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]

12.  Secondary:   Percentage of Participants Requiring Erythrocyte Transfusions   [ Time Frame: Visits 1 to 10 (Months -2 to 8) ]


  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: Hoffmannb-LaRoche
phone: 1-800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00413894     History of Changes
Other Study ID Numbers: ML20572
Study First Received: December 19, 2006
Results First Received: January 17, 2016
Last Updated: January 17, 2016
Health Authority: Germany: Ethics Commission