Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

This study has been terminated.
(Due to more robust long-term data generated in other active-controlled studies)
Sponsor:
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00372489
First received: September 5, 2006
Last updated: June 22, 2012
Last verified: June 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Renal Failure
Chronic Kidney Disease
Anemia
Intervention: Drug: peginesatide

  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
Peginesatide Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.

Participant Flow:   Overall Study
    Peginesatide  
STARTED     81  
COMPLETED     2  
NOT COMPLETED     79  
Adverse Event                 18  
Lack of Efficacy                 1  
Lost to Follow-up                 3  
Physician Decision                 3  
Withdrawal by Subject                 5  
Patient Relocation                 2  
Renal transplant                 6  
Sponsor Decision to Terminate Study                 41  



  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.
No text entered.

Reporting Groups
  Description
Peginesatide Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.

Baseline Measures
    Peginesatide  
Number of Participants  
[units: participants]
  81  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     51  
>=65 years     30  
Age  
[units: years]
Mean ± Standard Deviation
  59.8  ± 15.01  
Gender  
[units: participants]
 
Female     37  
Male     44  



  Outcome Measures

1.  Primary:   Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change   [ Time Frame: Up to 54 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Early termination of study due to generation of controlled long-term data in Phase 3 studies. Amended dosing guidelines during the trial to reflect label changes for ESAs; the primary outcome was assessed after the dosing guideline change.  


Results Point of Contact:  
Name/Title: VP, Clinical Development
Organization: Affymax
phone: 650-812-8700
e-mail: info@affymax.com


No publications provided


Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00372489     History of Changes
Other Study ID Numbers: AFX01-09
Study First Received: September 5, 2006
Results First Received: April 26, 2012
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board