Trial Outcomes & Findings for Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer® (NCT NCT02453334)
NCT ID: NCT02453334
Last Updated: 2021-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
Week 3 to Week 18
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Injectafer
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
81
|
82
|
|
Overall Study
NOT COMPLETED
|
41
|
40
|
Reasons for withdrawal
| Measure |
Injectafer
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Overall Study
Death
|
15
|
13
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
17
|
13
|
|
Overall Study
Other reason
|
1
|
4
|
Baseline Characteristics
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Baseline characteristics by cohort
| Measure |
Injectafer
n=122 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=122 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
117 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African-American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Height
|
166.9 cm
STANDARD_DEVIATION 9.5 • n=5 Participants
|
165.9 cm
STANDARD_DEVIATION 9.6 • n=7 Participants
|
166.4 cm
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Iron intolerance
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Iron intolerance
No
|
119 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
ECOG grade
0
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
ECOG grade
1
|
75 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
ECOG grade
2
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
ECOG grade
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG grade
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer stage
0
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Cancer stage
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer stage
2
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Cancer stage
3
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Cancer stage
4
|
81 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Cancer stage
Unknown
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3 to Week 18The 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.
Outcome measures
| Measure |
Injectafer
n=121 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
|
42 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
Nonstudy Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Baseline
|
9.63 g/dL
Standard Deviation 1.000
|
9.75 g/dL
Standard Deviation 1.008
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Day 7 Change from Baseline
|
0.27 g/dL
Standard Deviation 0.901
|
0.01 g/dL
Standard Deviation 0.741
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 2 Change from Baseline
|
0.53 g/dL
Standard Deviation 1.077
|
0.06 g/dL
Standard Deviation 0.937
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 3 Change from Baseline
|
0.58 g/dL
Standard Deviation 1.015
|
0.04 g/dL
Standard Deviation 1.028
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 6 Change from Baseline
|
0.84 g/dL
Standard Deviation 1.264
|
0.07 g/dL
Standard Deviation 1.254
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 9 Change from Baseline
|
0.85 g/dL
Standard Deviation 1.174
|
0.37 g/dL
Standard Deviation 1.512
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 12 Change from Baseline
|
1.00 g/dL
Standard Deviation 1.202
|
0.74 g/dL
Standard Deviation 1.274
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 15 Change from Baseline
|
0.97 g/dL
Standard Deviation 1.394
|
0.79 g/dL
Standard Deviation 1.313
|
|
Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Week 18/ET Change from Baseline
|
1.04 g/dL
Standard Deviation 1.718
|
0.87 g/dL
Standard Deviation 1.475
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
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.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
|
84 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants Who Received Nonstudy Intervention
|
22 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
Intervention is defined as any of the following: * Initiation of erythropoietin for any reason * Blood transfusion * IV iron * Prescribed use of oral iron
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
|
31 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
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
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Q1, 1st quartile
|
15 Days
Interval 15.0 to 20.0
|
23 Days
Interval 21.0 to 43.0
|
|
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Q2, 2nd quartile or median
|
43 Days
Interval 22.0 to 45.0
|
85 Days
Interval 64.0 to 106.0
|
|
Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Q3, 3rd quartile
|
106 Days
Interval 69.0 to
Not applicable because insufficient number of participants with events.
|
NA Days
Interval 126.0 to
Not applicable because insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants Requiring a Blood Transfusion
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 7Population: Only participant with both a baseline and at least one post baseline value at Day 7 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=112 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=112 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
18 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Only participant with both a baseline and at least one post baseline value at Week 2 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=107 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=100 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
17 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 3Population: Only participant with both a baseline and at least one post baseline value at Week 3 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=98 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=103 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
12 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Only participant with both a baseline and at least one post baseline value at Week 6 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=92 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=93 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
12 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 9Population: Only participant with both a baseline and at least one post baseline value at Week 9 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=85 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=79 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
9 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Only participant with both a baseline and at least one post baseline value at Week 12 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=76 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=67 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 15Population: Only participant with both a baseline and at least one post baseline value at Week 15 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=72 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=65 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Only participant with both a baseline and at least one post baseline value at Week 18 are included.
Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Outcome measures
| Measure |
Injectafer
n=69 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=63 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 18Patients 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.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Q1
|
15 Days
Interval 14.0 to 43.0
|
14 Days
Interval 8.0 to 15.0
|
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Q2
|
127 Days
Interval 106.0 to
Not available because of the insufficient number of participants with events.
|
43 Days
Interval 22.0 to 64.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
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.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Q1,1st quartile
|
15 Days
Interval 14.0 to 43.0
|
14 Days
Interval 8.0 to 15.0
|
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
2nd quartile or median
|
127 Days
Interval 106.0 to
Not available because insufficient number of participants with events.
|
43 Days
Interval 22.0 to 64.0
|
|
Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Q3, 3rd quartile
|
NA Days
Not available because insufficient number of participants with events.
|
NA Days
Interval 128.0 to
Not available because insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to Week 18.Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
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.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Hepcidin in 1st Tertile
|
0.88 g/dL
Standard Deviation 1.892
|
1.13 g/dL
Standard Deviation 1.203
|
|
Correlation of Change in Hemoglobin With Baseline Hepcidin Level
hepcidin in 3rd Tertile
|
1.28 g/dL
Standard Deviation 1.552
|
0.02 g/dL
Standard Deviation 1.394
|
SECONDARY outcome
Timeframe: Baseline to Week 18Population: Only subjects who completed the study from the Modified intention to treat (mITT) population.
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.
Outcome measures
| Measure |
Injectafer
n=119 Participants
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 Participants
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Baseline
|
21.8 Score on a scale
Standard Deviation 9.47
|
21.5 Score on a scale
Standard Deviation 8.64
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Day 7 Change from Baseline
|
-0.8 Score on a scale
Standard Deviation 6.78
|
-0.7 Score on a scale
Standard Deviation 6.21
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 2 Change from Baseline
|
-0.3 Score on a scale
Standard Deviation 7.34
|
0.2 Score on a scale
Standard Deviation 8.13
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 3 Change from Baseline
|
-0.3 Score on a scale
Standard Deviation 7.75
|
-0.6 Score on a scale
Standard Deviation 7.41
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 6 Change from Baseline
|
-0.2 Score on a scale
Standard Deviation 9.70
|
-0.7 Score on a scale
Standard Deviation 8.13
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 9 Change from Baseline
|
-0.7 Score on a scale
Standard Deviation 8.35
|
0.3 Score on a scale
Standard Deviation 8.22
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 12 Change from Baseline
|
-0.1 Score on a scale
Standard Deviation 9.82
|
-0.5 Score on a scale
Standard Deviation 8.09
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 15 Change from Baseline
|
-0.1 Score on a scale
Standard Deviation 9.65
|
0.8 Score on a scale
Standard Deviation 9.11
|
|
Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Week 18 Change from Baseline
|
-1.5 Score on a scale
Standard Deviation 8.78
|
0.0 Score on a scale
Standard Deviation 8.92
|
Adverse Events
Injectafer
Serious events: 28 serious events
Other events: 96 other events
Deaths: 0 deaths
Normal Saline
Serious events: 22 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Injectafer
n=121 participants at risk
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 participants at risk
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
5.8%
7/121 • Number of events 7 • 1 year, 7 months
|
0.00%
0/118 • 1 year, 7 months
|
|
General disorders
Disease progression
|
3.3%
4/121 • Number of events 4 • 1 year, 7 months
|
3.4%
4/118 • Number of events 4 • 1 year, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
0.85%
1/118 • Number of events 1 • 1 year, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
4.1%
5/121 • Number of events 5 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders
|
3.3%
4/121 • Number of events 4 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Infections and infestations
Infections And Infestations
|
3.3%
4/121 • Number of events 4 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
2.5%
3/121 • Number of events 3 • 1 year, 7 months
|
1.7%
2/118 • Number of events 2 • 1 year, 7 months
|
|
Cardiac disorders
Cardiac Disorders
|
1.7%
2/121 • Number of events 2 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
0.00%
0/121 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
Other adverse events
| Measure |
Injectafer
n=121 participants at risk
2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.
Injectafer
|
Normal Saline
n=118 participants at risk
Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Normal Saline
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.4%
15/121 • Number of events 15 • 1 year, 7 months
|
6.8%
8/118 • Number of events 8 • 1 year, 7 months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
11/121 • Number of events 11 • 1 year, 7 months
|
9.3%
11/118 • Number of events 11 • 1 year, 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
7/121 • Number of events 7 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Gastrointestinal disorders
Constipation
|
5.8%
7/121 • Number of events 7 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
General disorders
Fatigue
|
14.9%
18/121 • Number of events 18 • 1 year, 7 months
|
14.4%
17/118 • Number of events 17 • 1 year, 7 months
|
|
General disorders
Asthenia
|
8.3%
10/121 • Number of events 10 • 1 year, 7 months
|
9.3%
11/118 • Number of events 11 • 1 year, 7 months
|
|
General disorders
Pyrexia
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
9.3%
11/118 • Number of events 11 • 1 year, 7 months
|
|
Investigations
Neutrophil count decreased
|
6.6%
8/121 • Number of events 8 • 1 year, 7 months
|
3.4%
4/118 • Number of events 4 • 1 year, 7 months
|
|
Investigations
Platelet count decreased
|
6.6%
8/121 • Number of events 8 • 1 year, 7 months
|
4.2%
5/118 • Number of events 5 • 1 year, 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
3.4%
4/118 • Number of events 4 • 1 year, 7 months
|
|
Injury, poisoning and procedural complications
Gamma-glutamyltransferase increased
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
5.1%
6/118 • Number of events 6 • 1 year, 7 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.4%
21/121 • Number of events 21 • 1 year, 7 months
|
11.9%
14/118 • Number of events 14 • 1 year, 7 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.4%
15/121 • Number of events 15 • 1 year, 7 months
|
11.0%
13/118 • Number of events 13 • 1 year, 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
10/121 • Number of events 10 • 1 year, 7 months
|
8.5%
10/118 • Number of events 10 • 1 year, 7 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.7%
19/121 • Number of events 19 • 1 year, 7 months
|
2.5%
3/118 • Number of events 3 • 1 year, 7 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.1%
5/121 • Number of events 5 • 1 year, 7 months
|
5.9%
7/118 • Number of events 7 • 1 year, 7 months
|
|
Nervous system disorders
Neuropathy peripheral
|
1.7%
2/121 • Number of events 2 • 1 year, 7 months
|
8.5%
10/118 • Number of events 10 • 1 year, 7 months
|
|
Infections and infestations
Infections and Infestations
|
13.2%
16/121 • Number of events 16 • 1 year, 7 months
|
11.9%
14/118 • Number of events 14 • 1 year, 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
1.7%
2/118 • Number of events 2 • 1 year, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
9.1%
11/121 • Number of events 11 • 1 year, 7 months
|
14.4%
17/118 • Number of events 17 • 1 year, 7 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
4/121 • Number of events 4 • 1 year, 7 months
|
5.9%
7/118 • Number of events 7 • 1 year, 7 months
|
|
Vascular disorders
Vascular Disorders
|
9.1%
11/121 • Number of events 11 • 1 year, 7 months
|
6.8%
8/118 • Number of events 8 • 1 year, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
5.0%
6/121 • Number of events 6 • 1 year, 7 months
|
1.7%
2/118 • Number of events 2 • 1 year, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.7%
2/121 • Number of events 2 • 1 year, 7 months
|
5.1%
6/118 • Number of events 6 • 1 year, 7 months
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
3.3%
4/121 • Number of events 4 • 1 year, 7 months
|
5.1%
6/118 • Number of events 6 • 1 year, 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60