Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.
This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
244
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
The following participants will be considered to have met the primary endpoint: * Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. * Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. * Participants who have a non-study intervention prior to Week 18. * Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
Time frame: Week 3 to Week 18
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Nonstudy Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Time frame: Baseline to Week 18
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.
Time frame: Baseline to Week 18
Percentage of Participants Who Received Nonstudy Intervention
Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Time frame: Baseline to week 18
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Time frame: Baseline to week 18
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Compassionate Care Research Group, Inc.
Corona, California, United States
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States
Compassionate Care Research Group, Inc.
Riverside, California, United States
University Cancer Institute
Boynton Beach, Florida, United States
AR Development Solutions
Miami Lakes, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Bond Bond Clinic, P.A.
Winter Haven, Florida, United States
Joliet Oncology Hematology Associates
Joliet, Illinois, United States
MId-Illinois Hematology & Oncology Associates, Ltd.
Normal, Illinois, United States
...and 19 more locations
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively
Time frame: Baseline to Week 18
Percentage of Participants Requiring a Blood Transfusion
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Time frame: Baseline to week 18
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Day 7
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 2
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 3
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 6
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 9
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 12
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 15
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time frame: Baseline to Week 18
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time frame: Baseline to Week 18
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time frame: From Baseline to Week 18
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.
Time frame: Baseline to Week 18.
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.
Time frame: Baseline to Week 18