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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 
Overall Participants Analyzed 
[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 
[1] Cardiovascular disease history is based on the cardiovascular medical history case report form.
Baseline proteinuria level [1] 
[Units: Participants]
     
>= 1 g/g creat   686   711   1397 
< 1 g/g creat   1324   1315   2639 
[1] 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
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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 by ClinicalTrials.gov Identifier (NCT Number):

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