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A Study of Subcutaneous 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:
NCT00077623
First received: February 10, 2004
Last updated: April 26, 2016
Last verified: April 2016
Results First Received: March 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: epoetin alfa or beta
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
A total of 817 participants were enrolled in this study conducted from 03 March 2004 to 23 September 2005 at 92 centers worldwide.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 572 participants were randomized, of which 1 participant did not received the study drug.

Reporting Groups
  Description
RO0503821 (1x/2 Weeks) Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
RO0503821 (1x/4 Weeks) Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
Epoetin Reference Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.

Participant Flow:   Overall Study
    RO0503821 (1x/2 Weeks)     RO0503821 (1x/4 Weeks)     Epoetin Reference  
STARTED     190     191     191  
COMPLETED     154     148     159  
NOT COMPLETED     36     43     32  
Adverse Event                 1                 0                 1  
Withdrawal by Subject                 2                 10                 1  
Other-Non safety reason                 18                 15                 19  
Insufficient therapeutic response                 2                 0                 0  
Death                 12                 18                 11  
Failure to return                 1                 0                 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.
The analysis was done on safety population which included all participants who received at least one dose of study drug.

Reporting Groups
  Description
RO0503821 (1x/2 Weeks) Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
RO0503821 (1x/4 Weeks) Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
Epoetin Reference Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Total Total of all reporting groups

Baseline Measures
    RO0503821 (1x/2 Weeks)     RO0503821 (1x/4 Weeks)     Epoetin Reference     Total  
Number of Participants  
[units: participants]
  190     190     191     571  
Age  
[units: years]
Mean (Standard Deviation)
  60.5  (15.40)     62.5  (15.16)     60.4  (14.70)     61.1  (15.10)  
Gender  
[units: participants]
       
Female     82     73     81     236  
Male     108     117     110     335  



  Outcome Measures
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1.  Primary:   Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods   [ Time Frame: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36) ]

2.  Secondary:   Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration   [ Time Frame: Evaluation period (Week 29 to Week 36) ]

3.  Secondary:   Number of Participants With Red Blood Cell Transfusions   [ Time Frame: Up to Week 36 ]

4.  Secondary:   Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths   [ Time Frame: Up to week 52 ]

5.  Secondary:   Number of Participants With Marked Laboratory Abnormalities   [ Time Frame: Up to week 52 ]

6.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants   [ Time Frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52 ]

7.  Secondary:   Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants   [ Time Frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52 ]

8.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants   [ Time Frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52 ]

9.  Secondary:   Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants   [ Time Frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52 ]


  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: NCT00077623     History of Changes
Other Study ID Numbers: BA16740
Study First Received: February 10, 2004
Results First Received: March 24, 2016
Last Updated: April 26, 2016
Health Authority: United States: Food and Drug Administration