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Completed

NCT Number: NCT00401544

Darbepoetin Alfa With or Without Intravenous (IV) Iron

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Non-Myeloid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

Darbepoetin alfa administered by subcutaneous injection.

Other names: Aranesp®

IV iron dextran

Drug

Administered by intravenous (IV) injection.

Other names: INFeD®, Cosmofer®

Primary outcomes

  1. Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose

    Time frame: From Week 1 to Week 16

    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.

  2. Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage

    Time frame: From Week 1 to Week 16

    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 outcomes

  1. Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose

    Time frame: From Week 1 to Week 16

    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.

  2. Time to Achieve the Target Hemoglobin Level, by IV Iron Usage

    Time frame: From Week 1 to Week 16

    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.

  3. Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose

    Time frame: Baseline and Week 16

    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).

  4. Change From Baseline in Hemoglobin Concentration, by IV Iron Usage

    Time frame: Baseline and Week 16

    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).

  5. 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

    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.

  6. 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

    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.

  7. Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study

    Time frame: From Week 5 to Week 16

    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.

  8. Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose

    Time frame: From Week 1 to Week 16

    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.

  9. Number of Participants With a Hematopoietic Response, by IV Iron Usage

    Time frame: From Week 1 to Week 16

    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.

  10. Time to Hematopoietic Response, by Darbepoetin Alfa Dose

    Time frame: From Week 1 to Week 16

    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.

  11. Time to Hematopoietic Response, by IV Iron Usage

    Time frame: From Week 1 to Week 16

    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.

  12. Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose

    Time frame: Baseline and Week 16

    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.

  13. Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage

    Time frame: Baseline and Week 16

    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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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