Darbepoetin Alfa With or Without Intravenous (IV) Iron

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401544
• Other study ID #: 20060103
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2006
• Last updated: December 10, 2013
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: December 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Health and the FamilyRussia: Ministry of HealthUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Drug:
• darbepoetin alfa
Darbepoetin alfa administered by subcutaneous injection.
• IV iron dextran
Administered by intravenous (IV) injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose	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.	From Week 1 to Week 16	No
Primary	Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage	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.	From Week 1 to Week 16	No
Secondary	Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose	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.	From Week 1 to Week 16	No
Secondary	Time to Achieve the Target Hemoglobin Level, by IV Iron Usage	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.	From Week 1 to Week 16	No
Secondary	Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose	Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).	Baseline and Week 16	No
Secondary	Change From Baseline in Hemoglobin Concentration, by IV Iron Usage	Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).	Baseline and Week 16	No
Secondary	Number of Participants With = 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose	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.	From Week 1 to Week 16	No
Secondary	Number of Participants With = 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage	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.	From Week 1 to Week 16	No
Secondary	Number of Participants With = 1 Red Blood Cell Transfusion From Week 5 to End of Study	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.	From Week 5 to Week 16	No
Secondary	Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose	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.	From Week 1 to Week 16	No
Secondary	Number of Participants With a Hematopoietic Response, by IV Iron Usage	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.	From Week 1 to Week 16	No
Secondary	Time to Hematopoietic Response, by Darbepoetin Alfa Dose	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.	From Week 1 to Week 16	No
Secondary	Time to Hematopoietic Response, by IV Iron Usage	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.	From Week 1 to Week 16	No
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose	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.	Baseline and Week 16	No
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage	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.	Baseline and Week 16	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling