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Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

This study has been terminated.
(The study was terminated due to the slow recruitment rate.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517881
First received: August 16, 2007
Last updated: April 21, 2016
Last verified: April 2016
Results First Received: April 21, 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 (C.E.R.A.)

  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
No text entered.

Reporting Groups
  Description
C.E.R.A. Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.

Participant Flow:   Overall Study
    C.E.R.A.
STARTED   29 
COMPLETED   24 
NOT COMPLETED   5 
Protocol Violation                2 
Adverse Event                1 
Renal transplantation                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.
The safety population included all participants who were treated with at least 1 dose of the study drug and a safety follow-up, whether withdrawn prematurely or not.

Reporting Groups
  Description
C.E.R.A. Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.

Baseline Measures
   C.E.R.A. 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (11.29) 
Gender 
[Units: Participants]
 
Female   18 
Male   11 


  Outcome Measures
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1.  Primary:   Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range   [ Time Frame: Week 17 up to Week 24 ]

2.  Secondary:   Change in Hemoglobin Concentration Between Reference (SVP) and EEP   [ Time Frame: Week 17 up to Week 24 ]

3.  Secondary:   Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP   [ Time Frame: Week 17 up to Week 24 ]

4.  Secondary:   Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP   [ Time Frame: Week 17 up to Week 24 ]

5.  Secondary:   Percentage of Participants Requiring Any Dose Adjustment   [ Time Frame: Week 1 up to Week 16 and Week 17 up to Week 24 ]

6.  Secondary:   Percentage of Participants With Red Blood Cell Transfusion During the Study   [ Time Frame: Week 0 up to Week 24 ]

7.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Week 0 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
The study was terminated early due to the slow recruitment rate.


  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-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517881     History of Changes
Other Study ID Numbers: ML20944
2006-006523-40 ( EudraCT Number )
Study First Received: August 16, 2007
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: Sweden: Medical Products Agency