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Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00093015
First received: September 28, 2004
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: August 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Kidney Disease
Diabetes Mellitus
Anemia
Interventions: Drug: Placebo
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
First Subject Enrolled: 25 Aug 2004 Last Subject Enrolled: 04 Dec 2007

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
Placebo Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
Darbepoetin Alfa Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.

Participant Flow:   Overall Study
    Placebo     Darbepoetin Alfa  
STARTED     2026     2012  
Received Study Medication     2019     2004  
COMPLETED     1361     1348  
NOT COMPLETED     665     664  
Withdrawal by Subject                 194                 171  
Lost to Follow-up                 96                 108  
Death                 375                 385  



  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
Darbepoetin Alfa Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
Placebo Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
Total Total of all reporting groups

Baseline Measures
    Darbepoetin Alfa     Placebo     Total  
Number of Participants  
[units: participants]
  2012     2026     4038  
Age  
[units: Years]
Mean ± Standard Deviation
  67.2  ± 10.7     67.5  ± 10.6     67.4  ± 10.6  
Gender  
[units: Participants]
     
Female     1178     1134     2312  
Male     834     892     1726  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     1270     1300     2570  
Black or African American     414     401     815  
Hispanic or Latino     273     265     538  
Asian     35     43     78  
Japanese     8     3     11  
American Indian or Alaska Native     1     4     5  
Native Hawaiian or Other Pacific Islander     4     5     9  
Aborigine     2     1     3  
Other     5     4     9  
History of cardiovascular disease [1]
[units: Participant]
     
With history of cardiovascular disease     1287     1355     2642  
Without history of cardiovascular disease     725     671     1396  
Baseline proteinuria level [2]
[units: Participants]
     
>= 1 g/g creat     686     711     1397  
< 1 g/g creat     1324     1315     2639  
[1] Cardiovascular disease history is based on the cardiovascular medical history case report form.
[2] Baseline proteinuria level (g/g creat). Baseline proteinuria is defined as the last non-missing measurement prior or on the day of first investigational product.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

2.  Primary:   Time to All-cause Mortality or End Stage Renal Disease (ESRD)   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

3.  Secondary:   Time to All-cause Mortality   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

4.  Secondary:   Time to Cardiovascular Mortality   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

5.  Secondary:   Time to Myocardial Infarction   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

6.  Secondary:   Time to Cerebrovascular Accident   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

7.  Secondary:   Time to Congestive Heart Failure   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

8.  Secondary:   Time to End Stage Renal Disease   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

9.  Secondary:   Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]

10.  Secondary:   Change in Patient Reported Fatigue Relative to Baseline at Week 25   [ Time Frame: Baseline and week 25 ]

11.  Secondary:   Time to Hospitalization Due to Acute Myocardial Ischemia   [ Time Frame: Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first ]


  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
4047 subjects were enrolled, but before unblinding, all information from 9 subjects was excluded from two sites (3 and 6 subjects, respectively) that did not adhere to Good Clinical Practice guidelines. 4038 subjects were analyzed and reported.


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Publications automatically indexed to this study:


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00093015     History of Changes
Other Study ID Numbers: 20010184, TREAT
Study First Received: September 28, 2004
Results First Received: August 6, 2010
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration