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Study Complete
Sponsor ID
20060103

darbepoetin alfa with or without intravenous (IV) iron

Sponsor ID
20060103
Clinicaltrials.gov ID
NCT00401544
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
243
Additional Study Details

Protocol Summary

Primary Outcome Measures

Achieved the Target Hemoglobin (Dose)

Timeframe: 15 weeks

Achieved the Target Hemoglobin (Iron)

Timeframe: 15 weeks

Secondary Outcome Measures

Time to Achieve the Target Hemoglobin (Dose)

Timeframe: Baseline to the end of the treatment period (Week 13)

Proportion of Participants with ≥ 1 RBC Transfusion from Week 5 to EOS

Timeframe: Week 5 to End of Study (Week 15)

Change from Baseline to EOTP in HRQOL (Dose)

Timeframe: Baseline to end of treatment period (Week 13)

Change from Baseline to EOTP in HRQOL (Iron)

Timeframe: Baseline to end of treatment period (Week 13)

Proportion of Participants with a Hematopoietic Response (Dose)

Timeframe: Baseline to the end of the treatment period (Week 13)

Proportion of Participants with a Hematopoietic Response (Iron)

Timeframe: Baseline to end of treatment period (Week 13)

Time to Hematopoietic Response (Dose)

Timeframe: Baseline to end of treatment period (Week 13)

Time to Hematopoietic Response (Iron)

Timeframe: Baseline to end of treatment period (Week 13)

Change in Hemoglobin Concentration (Dose)

Timeframe: Baseline to the end of the treatment period (Week 13)

Change in Hemoglobin Concentration (Iron)

Timeframe: Baseline to the end of the treatment period (Week 13)

Time to Achieve the Target Hemoglobin (Iron)

Timeframe: Baseline to the end of the treatment period (Week 13)

Proportion of Participants with ≥ 1 RBC Transfusion from Week 1 to EOS (Dose)

Timeframe: Week 1 to end of study (Week 15)

Proportion of Participants with ≥ 1 RBC Transfusion from Week 1 to EOS (Iron)

Timeframe: Week 1 to end of study (Week 15)

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
    • Show more
  • Anemia of Cancer
    • Sex
    All
    Trial Dates
    Dec 2006 - Dec 2007
    Inclusion and Exclusion 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
    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