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Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 1)

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00598273
First received: January 10, 2008
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Renal Failure
Chronic Kidney Disease
Anemia
Interventions: Drug: peginesatide
Drug: Darbepoetin alfa

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Peginesatide 0.025 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Participant Flow:   Overall Study
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa  
STARTED     161     165     164  
COMPLETED     120     127     125  
NOT COMPLETED     41     38     39  
Adverse Event                 4                 5                 2  
Death                 6                 12                 8  
Lost to Follow-up                 8                 3                 5  
Physician Decision                 0                 0                 1  
Withdrawal by Subject                 12                 10                 10  
Noncompliance                 3                 2                 3  
Relocation                 0                 2                 4  
Renal transplant                 1                 0                 1  
Site elected to close                 1                 0                 0  
Started dialysis                 6                 4                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Peginesatide 0.025 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Total Total of all reporting groups

Baseline Measures
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa     Total  
Number of Participants  
[units: participants]
 		  161     165     164     490  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     70     63     65     198  
>=65 years     91     102     99     292  
Age  
[units: years]
Mean ± Standard Deviation 		  67.1  ± 13.51     67.1  ± 12.73     66.4  ± 14.25     66.9  ± 13.49  
Gender  
[units: participants]
 		       
Female     93     84     102     279  
Male     68     81     62     211  



  Outcome Measures
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1.  Primary:   Mean Change in Hemoglobin Between Baseline and the Evaluation Period   [ Time Frame: Baseline and Weeks 25-36 ]
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2.  Secondary:   Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods   [ Time Frame: Weeks 0 to 36 ]
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3.  Secondary:   Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.   [ Time Frame: Weeks 0 to 36 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: Affymax
ClinicalTrials.gov Identifier: NCT00598273     History of Changes
Other Study ID Numbers: AFX01-11
Study First Received: January 10, 2008
Results First Received: April 26, 2012
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board