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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
  Purpose

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.


Condition Intervention Phase
Anemia
Non-Myeloid Malignancies
Drug: darbepoetin alfa
Drug: IV iron dextran
Phase 2

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
Official Title: Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 243
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Drug: darbepoetin alfa
Darbepoetin alfa administered by subcutaneous injection.
Other Name: Aranesp®
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).
Drug: darbepoetin alfa
Darbepoetin alfa administered by subcutaneous injection.
Other Name: Aranesp®
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).
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401544

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
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

Keywords provided by Amgen:
anemia
chemotherapy induced anemia
darbepoetin alfa
cancer

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014