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

November 16, 2006
December 10, 2013
December 2006
December 2007   (final data collection date for primary outcome measure)
  • Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
  • Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
The proportion of subjects who achieve the target hemoglobin (Hgb 11 g/dL) during the treatment period in the absence of a RBC transfusion within the prior 28 days
Complete list of historical versions of study NCT00401544 on ClinicalTrials.gov Archive Site
  • Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
  • Time to Achieve the Target Hemoglobin Level, by IV Iron Usage [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
  • Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
  • Change From Baseline in Hemoglobin Concentration, by IV Iron Usage [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
  • 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 ] [ Designated as safety issue: No ]
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
  • 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 ] [ Designated as safety issue: No ]
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
  • Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study [ Time Frame: From Week 5 to Week 16 ] [ Designated as safety issue: No ]
    Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
  • Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.
  • Number of Participants With a Hematopoietic Response, by IV Iron Usage [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.
  • Time to Hematopoietic Response, by Darbepoetin Alfa Dose [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
  • Time to Hematopoietic Response, by IV Iron Usage [ Time Frame: From Week 1 to Week 16 ] [ Designated as safety issue: No ]
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
  • Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
  • Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
Time to achieving target hemoglobin (Hgb 11 g/dL)
Not Provided
Not Provided
 
Darbepoetin Alfa With or Without Intravenous (IV) Iron
Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia
  • Non-Myeloid Malignancies
  • Drug: darbepoetin alfa
    Darbepoetin alfa administered by subcutaneous injection.
    Other Name: Aranesp®
  • Drug: IV iron dextran
    Administered by intravenous (IV) injection.
    Other Names:
    • INFeD®
    • Cosmofer®
  • Experimental: Darbepoetin alfa 300 μg plus IV 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).
    Interventions:
    • Drug: darbepoetin alfa
    • Drug: IV iron dextran
  • Experimental: Darbepoetin alfa 300 μg
    Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Intervention: Drug: darbepoetin alfa
  • Experimental: Darbepoetin alfa 500 μg
    Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Intervention: Drug: darbepoetin alfa
  • Active Comparator: Darbepoetin alfa 500 μg plus IV 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).
    Interventions:
    • Drug: darbepoetin alfa
    • Drug: IV iron dextran
Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010 Sep;85(9):655-63. doi: 10.1002/ajh.21779.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
March 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active non myeloid malignancy(cies) including lymphocytic leukemias
  • Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
  • Anemia due to chemotherapy (screening Hgb <or = 10.0 g/dL)
  • at least 18 years of age at screening

Exclusion Criteria:

  • Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
  • Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
  • Active bleeding
  • Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
  • Active, unstable systemic or chronic infection
  • Planned elective surgery during the study where significant blood loss is expected
  • Unstable angina, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)
  • History of pure red cell aplasia (PRCA)
  • History of deep venous thrombosis
  • Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
  • Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening
  • Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
  • Currently receiving or planned to receive myeloablative radiation therapy
  • Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
  • Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
  • Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
  • Known sensitivity to iron administration
  • Pregnant or breast feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00401544
20060103
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP