Darbepoetin Alfa With or Without Intravenous (IV) Iron

NCT ID: NCT00401544

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

Brief Summary

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.

Conditions

Anemia; Non-Myeloid Malignancies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

darbepoetin alfa

Intervention Type: DRUG

Darbepoetin alfa administered by subcutaneous injection.

IV iron dextran

Intervention Type: DRUG

Administered by intravenous (IV) injection.

Darbepoetin alfa 300 μg

Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Group Type: EXPERIMENTAL

darbepoetin alfa

Intervention Type: DRUG

Darbepoetin alfa administered by subcutaneous injection.

Darbepoetin alfa 500 μg

Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

Group Type: EXPERIMENTAL

darbepoetin alfa

Intervention Type: DRUG

Darbepoetin alfa administered by subcutaneous injection.

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).

Group Type: ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type: DRUG

Darbepoetin alfa administered by subcutaneous injection.

IV iron dextran

Intervention Type: DRUG

Administered by intravenous (IV) injection.

Interventions

darbepoetin alfa

Darbepoetin alfa administered by subcutaneous injection.

Intervention Type: DRUG

IV iron dextran

Administered by intravenous (IV) injection.

Intervention Type: DRUG

Other Intervention Names

Aranesp®; INFeD®; Cosmofer®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 mug 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.

Reference Type: RESULT

PMID: 20661916 (View on PubMed)

Related Links

http://www.aranesp.com/

FDA-approved Drug Labeling

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20060103

Identifier Type: -

Identifier Source: org_study_id