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Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 2)

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00598442
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
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 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 darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and 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     167     163     163  
COMPLETED     124     124     139  
NOT COMPLETED     43     39     24  
Adverse Event                 3                 0                 0  
Death                 19                 11                 11  
Lost to Follow-up                 4                 3                 3  
Physician Decision                 2                 1                 1  
Withdrawal by Subject                 8                 16                 6  
Noncompliance                 0                 2                 1  
Relocation                 1                 4                 0  
Renal transplant                 0                 0                 1  
Site closed by sponsor                 5                 2                 1  
Started dialysis                 1                 0                 0  



  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 darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and 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]
 		  167     163     163     493  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     63     57     62     182  
>=65 years     104     106     101     311  
Age  
[units: years]
Mean ± Standard Deviation 		  68.1  ± 12.93     68.3  ± 13.53     67.2  ± 15.03     67.9  ± 13.83  
Gender  
[units: participants]
 		       
Female     93     96     99     288  
Male     74     67     64     205  



  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 Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods   [ Time Frame: Weeks 0 to 36 ]
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Measure Type Secondary
Measure Title Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
Measure Description No text entered.
Time Frame Weeks 0 to 36  
Safety Issue No  

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.
Full Analysis Population: All randomized participants who received at least one dose of study medication

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 darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Measured Values
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa  
Number of Participants Analyzed  
[units: participants]
 		  167     163     163  
Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods  
[units: percentage of participants]
 		  0.114     0.104     0.049  


Statistical Analysis 1 for Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
Groups [1] Peginesatide 0.025 mg/kg vs. Darbepoetin Alfa
Risk Ratio (RR) [2] 2.28
95% Confidence Interval ( 1.04 to 5.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
Groups [1] Peginesatide 0.04 mg/kg vs. Darbepoetin Alfa
Risk Ratio (RR) [2] 2.10
95% Confidence Interval ( 0.94 to 4.69 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



3.  Secondary:   Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods   [ Time Frame: Weeks 0 to 36 ]
  Show Outcome Measure 3


  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
No text entered.  


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: NCT00598442     History of Changes
Other Study ID Numbers: AFX01-13, 2007-004146-32
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
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Scientific and Medical Research Council Ethics Committee
Italy: The Italian Medicines Agency
Italy: Ethics Committee
Poland: The Central Register of Clinical Trials
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Romania: National Medicines Agency
Romania: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee