AnemiaPhase 2NCT00401544
Darbepoetin Alfa With or Without Intravenous (IV) Iron
A Phase 2 study testing darbepoetin alfa and IV iron dextran in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Non-Myeloid Malignancies
- What is being tested?
- darbepoetin alfa and IV iron dextran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
About this study
Official title: 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.
- Conditions
- Anemia, Non-Myeloid Malignancies
- Being tested
- darbepoetin alfa, IV iron dextran
- Keywords
- anemia, chemotherapy induced anemia, darbepoetin alfa, cancer
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin alfaDrug
Also called Aranesp®
Darbepoetin alfa administered by subcutaneous injection.
IV iron dextranDrug
Also called INFeD®, Cosmofer®
Administered by intravenous (IV) injection.
| Study group | Role | What they receive |
|---|---|---|
| Darbepoetin alfa 300 μg plus IV Iron | Experimental | 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). Receives: Drug: darbepoetin alfa; Drug: IV iron dextran |
| Darbepoetin alfa 300 μg | Experimental | Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). Receives: Drug: darbepoetin alfa |
| Darbepoetin alfa 500 μg | Experimental | Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). Receives: Drug: darbepoetin alfa |
| Darbepoetin alfa 500 μg plus IV Iron | Active comparator | 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). Receives: Drug: darbepoetin alfa; Drug: IV iron dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
Secondary outcomes (13)
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
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).
Measured: Baseline and Week 16
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).
Measured: Baseline and Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 5 to Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: From Week 1 to Week 16
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.
Measured: Baseline and Week 16
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.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401544
- Sponsor's protocol ID
- 20060103
- Status last verified
- Dec 2013
- First submitted
- 16 Nov 2006
- Last updated
- 29 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20661916
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT00401544
- Acronym / sponsor ID
- 20060103
- Conditions
- Anemia, Non-Myeloid Malignancies
- Keywords
- anemia, chemotherapy induced anemia, darbepoetin alfa, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Posted 29 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Darbepoetin alfa 300 μg plus IV Iron | Experimental | Drug: darbepoetin alfa, Drug: IV iron dextranDarbepoetin 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). |
| Darbepoetin alfa 300 μg | Experimental | Drug: darbepoetin alfaDarbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Darbepoetin alfa 500 μg | Experimental | Drug: darbepoetin alfaDarbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses). |
| Darbepoetin alfa 500 μg plus IV Iron | Active comparator | Drug: darbepoetin alfa, Drug: IV iron dextranDarbepoetin 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| darbepoetin alfaAlso: Aranesp®Darbepoetin alfa administered by subcutaneous injection. | Drug | Darbepoetin alfa 300 μg, Darbepoetin alfa 300 μg plus IV Iron, Darbepoetin alfa 500 μg, Darbepoetin alfa 500 μg plus IV Iron |
| IV iron dextranAlso: INFeD®, Cosmofer®Administered by intravenous (IV) injection. | Drug | Darbepoetin alfa 300 μg plus IV Iron, Darbepoetin alfa 500 μg plus IV Iron |
Primary outcome
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.
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.
13 secondary outcomes
Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
Time frame: From Week 1 to Week 16
Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
Time frame: From Week 1 to Week 16
Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
Time frame: Baseline and Week 16
Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
Time frame: Baseline and 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
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
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 a Hematopoietic Response, by Darbepoetin Alfa Dose
Time frame: From Week 1 to Week 16
Number of Participants With a Hematopoietic Response, by IV Iron Usage
Time frame: From Week 1 to Week 16
Time to Hematopoietic Response, by Darbepoetin Alfa Dose
Time frame: From Week 1 to Week 16
Time to Hematopoietic Response, by IV Iron Usage
Time frame: From Week 1 to Week 16
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
Time frame: Baseline and Week 16
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
Time frame: Baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20661916Auerbach 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.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing darbepoetin alfa and IV iron dextran in people with Anemia and Non-Myeloid Malignancies, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose (time frame: From Week 1 to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.