This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
287
Administered subcutaneously.
Number of Participants Hospitalized During the Test Period
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
Time frame: Weeks 1- 12
Days of Hospitalization During the Test Period
Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.
Time frame: Weeks 1-12
Number of Hospitalizations During the Test Period
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
Time frame: Weeks 1-12
Total Hospital Costs During the Test Period
The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.
Time frame: Weeks 1-12
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.
Time frame: Baseline (Week 1) and Week 13
Hemoglobin Response During the Test Period
The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
Time frame: Weeks 1-12
Hematopoietic Response During the Test Period
The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
Time frame: Weeks 1-12
Change From Baseline in Hemoglobin Level
The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).
Time frame: Baseline (Week 1) and Week 13
Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
Number of participants with at least one RBC transfusion during Weeks 1 to 12.
Time frame: Weeks 1-12
Number of Units of Red Blood Cells Transfused During the Test Period
The average number of standard units of red blood cells transfused during Weeks 1 to 12.
Time frame: Weeks 1-12
Number of Days of Red Blood Cell Transfusions During the Test Period
The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
Time frame: Weeks 1-12
Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
The number of participants with at least one RBC transfusion during weeks 5 to 12.
Time frame: Weeks 5-12
Number of Units of Red Blood Cells Transfused During Weeks 5-12
The number of standard units of RBCs transfused during Weeks 5 to 12.
Time frame: Weeks 5-12
Number of Days of Red Blood Cell Transfusions During Weeks 5-12
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
Time frame: Weeks 5-12
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