A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922116
First received: June 16, 2009
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: November 4, 2015  
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
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Mircera Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.

Participant Flow:   Overall Study
    Mircera  
STARTED     191  
COMPLETED     176  
NOT COMPLETED     15  
Adverse Event                 4  
Death                 1  
Lost to Follow-up                 1  
Withdrawal by Subject                 4  
Unspecified                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

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 defined as all participants who participated in the trial.

Reporting Groups
  Description
Mircera Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.

Baseline Measures
    Mircera  
Number of Participants  
[units: participants]
  191  
Age  
[units: years]
Mean (Standard Deviation)
  60.4  (12.9)  
Gender  
[units: participants]
 
Female     114  
Male     77  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)   [ Time Frame: EEP (Weeks 17 to 24) ]

2.  Secondary:   Change in Hemoglobin Concentration Between SVP and the EEP   [ Time Frame: SVP (Baseline), and EEP (Weeks 17 to 24) ]

3.  Secondary:   Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP   [ Time Frame: EEP (Weeks 17 to 24) ]

4.  Secondary:   Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP   [ Time Frame: Weeks 1 to 24 ]

5.  Secondary:   Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP   [ Time Frame: Weeks 1 to 24 ]

6.  Secondary:   Average Dose of Mircera Per Month   [ Time Frame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: NCT00922116     History of Changes
Other Study ID Numbers: ML22285
Study First Received: June 16, 2009
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: Korea:FDA