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Darbepoetin Alfa With or Without Intravenous (IV) Iron

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00401544
First received: November 16, 2006
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: March 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anemia
Non-Myeloid Malignancies
Interventions: Drug: darbepoetin alfa
Drug: IV iron dextran

  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
Participants were enrolled from 18 December 2006 through 27 August 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 243 patients were randomizd and 238 received study drug (4 participants in the Darbepoetin alfa 300 μg plus Iron group and 1 in the Darbepoetin alfa 500 μg plus Iron group were not treated)

Reporting Groups
  Description
Darbepoetin Alfa 300 μg Plus Iron Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 300 μg Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Participant Flow:   Overall Study
    Darbepoetin Alfa 300 μg Plus Iron     Darbepoetin Alfa 300 μg     Darbepoetin Alfa 500 μg Plus Iron     Darbepoetin Alfa 500 μg  
STARTED     56 [1]   62 [1]   60 [1]   60 [1]
COMPLETED     38     44     48     44  
NOT COMPLETED     18     18     12     16  
Adverse Event                 5                 1                 1                 1  
Death                 3                 6                 2                 5  
Lost to Follow-up                 2                 0                 1                 1  
Withdrawal by Subject                 7                 6                 6                 5  
Physician Decision                 1                 3                 0                 0  
Ineligibility determined                 0                 1                 0                 2  
Disease progression                 0                 1                 0                 0  
Other                 0                 0                 2                 2  
[1] Randomized and treated



  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.
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Reporting Groups
  Description
Darbepoetin Alfa 300 μg Plus Iron Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 300 μg Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Total Total of all reporting groups

Baseline Measures
    Darbepoetin Alfa 300 μg Plus Iron     Darbepoetin Alfa 300 μg     Darbepoetin Alfa 500 μg     Darbepoetin Alfa 500 μg Plus Iron     Total  
Number of Participants  
[units: participants]
  56     62     60     60     238  
Age  
[units: Years]
Mean ± Standard Deviation
  61.2  ± 12.5     62.1  ± 14.1     66.7  ± 12.0     62.3  ± 13.3     63.1  ± 13.1  
Gender  
[units: Participants]
         
Female     34     44     33     47     158  
Male     22     18     27     13     80  
Race/Ethnicity, Customized  
[units: Participants]
         
Black or African American     7     5     9     11     32  
Hispanic or Latino     2     7     1     3     13  
Asian     2     1     0     0     3  
Other     0     1     0     0     1  
White or Caucasian     45     48     50     46     189  
FACT-Fatigue Score [1]
[units: Units on a scale]
Mean ± Standard Deviation
  28.54  ± 12.32     30.24  ± 12.46     28.60  ± 11.95     30.25  ± 11.79     29.44  ± 12.08  
Hemoglobin  
[units: g/dL]
Mean ± Standard Deviation
  9.4  ± 1.1     9.4  ± 0.9     9.4  ± 1.2     9.2  ± 0.9     9.4  ± 1.0  
[1] Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale score, ranging from 0 to 52, where 0 = worst outcome and higher scores represent less fatigue.



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose   [ Time Frame: From Week 1 to Week 16 ]

2.  Primary:   Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage   [ Time Frame: From Week 1 to Week 16 ]

3.  Secondary:   Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose   [ Time Frame: From Week 1 to Week 16 ]

4.  Secondary:   Time to Achieve the Target Hemoglobin Level, by IV Iron Usage   [ Time Frame: From Week 1 to Week 16 ]

5.  Secondary:   Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose   [ Time Frame: Baseline and Week 16 ]

6.  Secondary:   Change From Baseline in Hemoglobin Concentration, by IV Iron Usage   [ Time Frame: Baseline and Week 16 ]

7.  Secondary:   Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose   [ Time Frame: From Week 1 to Week 16 ]

8.  Secondary:   Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage   [ Time Frame: From Week 1 to Week 16 ]

9.  Secondary:   Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study   [ Time Frame: From Week 5 to Week 16 ]

10.  Secondary:   Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose   [ Time Frame: From Week 1 to Week 16 ]

11.  Secondary:   Number of Participants With a Hematopoietic Response, by IV Iron Usage   [ Time Frame: From Week 1 to Week 16 ]

12.  Secondary:   Time to Hematopoietic Response, by Darbepoetin Alfa Dose   [ Time Frame: From Week 1 to Week 16 ]

13.  Secondary:   Time to Hematopoietic Response, by IV Iron Usage   [ Time Frame: From Week 1 to Week 16 ]

14.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose   [ Time Frame: Baseline and Week 16 ]

15.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage   [ Time Frame: Baseline and Week 16 ]


  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
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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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications of Results:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00401544     History of Changes
Other Study ID Numbers: 20060103
Study First Received: November 16, 2006
Results First Received: March 4, 2011
Last Updated: December 10, 2013
Health Authority: Romania: Ministry of Health and the Family
Russia: Ministry of Health
United States: Food and Drug Administration
United States: Institutional Review Board