Trial Outcomes & Findings for Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (NCT NCT03238911)
NCT ID: NCT03238911
Last Updated: 2020-02-25
Results Overview
Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
Baseline to day 35
Results posted on
2020-02-25
Participant Flow
A total of 310 subjects were screened and 123 subjects were randomised into the trial.
Participant milestones
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit.
|
Ferric Carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg).
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
Safety Analysis Set
|
63
|
60
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit.
|
Ferric Carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Baseline characteristics by cohort
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
46.3 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
45.1 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/American Indian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/American Indian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
60 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
Iron Deficiency Anaemia (IDA) due to gynaecological blood loss
Yes
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Iron Deficiency Anaemia (IDA) due to gynaecological blood loss
No
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Current smoker
Yes
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Current smoker
No
|
57 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
S-phosphate level at screening
<3.5 mg/dL
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
S-phosphate level at screening
≥3.5 mg/dL
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
|
5 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Time with hypophosphatemia (i.e. time with s-phosphate level \< 2.0 mg/dL) from baseline up to day 35. The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was \<2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
|
15 days
Interval 7.0 to 56.0
|
29 days
Interval 21.0 to 42.0
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=59 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=58 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL)
|
1 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Absolute \[∆\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
0.25 mg/dL
Standard Deviation 0.55
|
-0.24 mg/dL
Standard Deviation 0.61
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
-0.06 mg/dL
Standard Deviation 0.75
|
-1.15 mg/dL
Standard Deviation 0.63
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
-0.10 mg/dL
Standard Deviation 0.77
|
-1.15 mg/dL
Standard Deviation 0.64
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
-0.04 mg/dL
Standard Deviation 0.75
|
-1.44 mg/dL
Standard Deviation 0.83
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
0.04 mg/dL
Standard Deviation 0.69
|
-1.02 mg/dL
Standard Deviation 0.99
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
0.24 mg/dL
Standard Deviation 0.76
|
-0.92 mg/dL
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Relative \[%\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
1.13 Percentage change from baseline
Standard Deviation 25.21
|
-42.59 Percentage change from baseline
Standard Deviation 24.81
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
9.31 Percentage change from baseline
Standard Deviation 18.98
|
-5.94 Percentage change from baseline
Standard Deviation 16.59
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
0.55 Percentage change from baseline
Standard Deviation 23.15
|
-33.68 Percentage change from baseline
Standard Deviation 17.53
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
-0.95 Percentage change from baseline
Standard Deviation 24.02
|
-34.03 Percentage change from baseline
Standard Deviation 17.61
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
2.85 Percentage change from baseline
Standard Deviation 22.66
|
-30.11 Percentage change from baseline
Standard Deviation 30.79
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
9.69 Percentage change from baseline
Standard Deviation 24.55
|
-27.58 Percentage change from baseline
Standard Deviation 27.47
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35. Fractional excretion of phosphate (FEPi) is calculated as (\[phosphate in urine X creatinine in serum\]/\[phosphate in serum X creatinine in urine\]) X 100, and the unit is %.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 1
|
-1.73 percentage excreted
Standard Deviation 4.85
|
2.44 percentage excreted
Standard Deviation 5.09
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 7
|
0.56 percentage excreted
Standard Deviation 8.30
|
8.12 percentage excreted
Standard Deviation 9.16
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 8
|
1.21 percentage excreted
Standard Deviation 7.71
|
9.08 percentage excreted
Standard Deviation 11.30
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 14
|
0.10 percentage excreted
Standard Deviation 7.34
|
11.46 percentage excreted
Standard Deviation 13.53
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 21
|
0.78 percentage excreted
Standard Deviation 9.46
|
9.43 percentage excreted
Standard Deviation 12.33
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 35
|
-1.97 percentage excreted
Standard Deviation 7.29
|
4.90 percentage excreted
Standard Deviation 11.07
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
-2.7 pg/mL
Standard Deviation 28.6
|
103.6 pg/mL
Standard Deviation 89.5
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
6.8 pg/mL
Standard Deviation 26.9
|
70.3 pg/mL
Standard Deviation 78.4
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
4.9 pg/mL
Standard Deviation 25.2
|
305.9 pg/mL
Standard Deviation 262.3
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
-8.6 pg/mL
Standard Deviation 25.7
|
106.1 pg/mL
Standard Deviation 114.9
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
-0.9 pg/mL
Standard Deviation 39.7
|
66.7 pg/mL
Standard Deviation 96.6
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
-10.5 pg/mL
Standard Deviation 25.6
|
34.7 pg/mL
Standard Deviation 64.2
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-742.3 RU/mL
Standard Deviation 800.7
|
-390.2 RU/mL
Standard Deviation 665.7
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-723.6 RU/mL
Standard Deviation 801.6
|
-477.5 RU/mL
Standard Deviation 652.0
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-648.9 RU/mL
Standard Deviation 757.5
|
-284.2 RU/mL
Standard Deviation 638.6
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-717.9 RU/mL
Standard Deviation 798.2
|
-401.5 RU/mL
Standard Deviation 661.5
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
-678.1 RU/mL
Standard Deviation 783.5
|
-458.9 RU/mL
Standard Deviation 658.9
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-660.1 RU/mL
Standard Deviation 806.7
|
-481.3 RU/mL
Standard Deviation 653.7
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
0.04 ng/mL
Standard Deviation 2.26
|
0.32 ng/mL
Standard Deviation 2.26
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.81 ng/mL
Standard Deviation 3.34
|
-0.94 ng/mL
Standard Deviation 3.93
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.32 ng/mL
Standard Deviation 3.35
|
-0.07 ng/mL
Standard Deviation 5.07
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
0.71 ng/mL
Standard Deviation 5.17
|
-1.29 ng/mL
Standard Deviation 5.14
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.78 ng/mL
Standard Deviation 6.03
|
-0.90 ng/mL
Standard Deviation 4.70
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-0.24 ng/mL
Standard Deviation 6.44
|
-0.72 ng/mL
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
5.13 pg/mL
Standard Deviation 13.05
|
-20.57 pg/mL
Standard Deviation 17.56
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-19.92 pg/mL
Standard Deviation 24.57
|
-38.84 pg/mL
Standard Deviation 20.86
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-16.07 pg/mL
Standard Deviation 25.10
|
-39.63 pg/mL
Standard Deviation 27.11
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-3.31 pg/mL
Standard Deviation 15.93
|
-39.04 pg/mL
Standard Deviation 27.46
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
-3.37 pg/mL
Standard Deviation 16.45
|
-28.89 pg/mL
Standard Deviation 30.06
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-3.86 pg/mL
Standard Deviation 20.08
|
-17.94 pg/mL
Standard Deviation 26.15
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-0.02 ng/mL
Standard Deviation 0.41
|
0.13 ng/mL
Standard Deviation 0.51
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.30 ng/mL
Standard Deviation 0.49
|
0.72 ng/mL
Standard Deviation 0.78
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.19 ng/mL
Standard Deviation 0.69
|
0.71 ng/mL
Standard Deviation 0.84
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
0.13 ng/mL
Standard Deviation 0.60
|
0.95 ng/mL
Standard Deviation 0.98
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.12 ng/mL
Standard Deviation 0.93
|
0.75 ng/mL
Standard Deviation 0.93
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.06 ng/mL
Standard Deviation 0.89
|
0.60 ng/mL
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-1.3 pg/mL
Standard Deviation 20.2
|
0.7 pg/mL
Standard Deviation 21.3
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-4.6 pg/mL
Standard Deviation 26.6
|
7.8 pg/mL
Standard Deviation 26.6
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
1.8 pg/mL
Standard Deviation 27.9
|
2.6 pg/mL
Standard Deviation 29.2
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
3.2 pg/mL
Standard Deviation 30.6
|
16.7 pg/mL
Standard Deviation 33.7
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
-3.1 pg/mL
Standard Deviation 22.8
|
17.2 pg/mL
Standard Deviation 34.9
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.2 pg/mL
Standard Deviation 27.9
|
22.1 pg/mL
Standard Deviation 41.2
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product
Safety Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
0.04 mg/dL
Standard Deviation 0.18
|
0.00 mg/dL
Standard Deviation 0.20
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.02 mg/dL
Standard Deviation 0.16
|
-0.07 mg/dL
Standard Deviation 0.22
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.03 mg/dL
Standard Deviation 0.19
|
-0.03 mg/dL
Standard Deviation 0.20
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
0.02 mg/dL
Standard Deviation 0.22
|
-0.08 mg/dL
Standard Deviation 0.22
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.08 mg/dL
Standard Deviation 0.19
|
-0.03 mg/dL
Standard Deviation 0.21
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.02 mg/dL
Standard Deviation 0.21
|
-0.03 mg/dL
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-0.16 g/dL per g of iron
Standard Deviation 1.29
|
0.28 g/dL per g of iron
Standard Deviation 1.82
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.65 g/dL per g of iron
Standard Deviation 0.86
|
0.94 g/dL per g of iron
Standard Deviation 1.49
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.50 g/dL per g of iron
Standard Deviation 1.14
|
0.64 g/dL per g of iron
Standard Deviation 0.81
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
1.55 g/dL per g of iron
Standard Deviation 1.53
|
1.16 g/dL per g of iron
Standard Deviation 0.90
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
1.68 g/dL per g of iron
Standard Deviation 1.40
|
1.44 g/dL per g of iron
Standard Deviation 0.97
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
2.16 g/dL per g of iron
Standard Deviation 1.62
|
1.94 g/dL per g of iron
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
261.7 ng/mL
Standard Deviation 184.2
|
289.5 ng/mL
Standard Deviation 173.0
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
82.0 ng/mL
Standard Deviation 58.3
|
94.7 ng/mL
Standard Deviation 62.4
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
248.1 ng/mL
Standard Deviation 182.4
|
325.8 ng/mL
Standard Deviation 220.1
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
133.9 ng/mL
Standard Deviation 109.9
|
352.9 ng/mL
Standard Deviation 223.4
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
97.2 ng/mL
Standard Deviation 127.6
|
179.2 ng/mL
Standard Deviation 135.0
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
46.8 ng/mL
Standard Deviation 63.0
|
108.9 ng/mL
Standard Deviation 107.3
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
118.9 percentage of saturation
Standard Deviation 52.0
|
85.7 percentage of saturation
Standard Deviation 40.4
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
10.2 percentage of saturation
Standard Deviation 34.8
|
12.9 percentage of saturation
Standard Deviation 11.2
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
6.3 percentage of saturation
Standard Deviation 34.7
|
61.2 percentage of saturation
Standard Deviation 43.0
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
4.8 percentage of saturation
Standard Deviation 32.6
|
16.4 percentage of saturation
Standard Deviation 11.3
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
6.8 percentage of saturation
Standard Deviation 31.1
|
16.6 percentage of saturation
Standard Deviation 11.7
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
3.1 percentage of saturation
Standard Deviation 32.3
|
14.7 percentage of saturation
Standard Deviation 10.8
|
POST_HOC outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Incidence of hypophosphatemia (defined as s-phosphate level ≤1 mg/dL) at any time from baseline up to day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=59 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35
|
0 Participants
|
7 Participants
|
Adverse Events
Iron Isomaltoside/Ferric Derisomaltose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ferric Carboxymaltose
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 participants at risk
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
1.6%
1/63 • Number of events 1 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
0.00%
0/60 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
Other adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=63 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=60 participants at risk
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/63 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
21.7%
13/60 • Number of events 13 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/63 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
20.0%
12/60 • Number of events 12 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/63 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
6.7%
4/60 • Number of events 6 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Before 1 year after completion of the Study report the Investigator must not publish details regarding the Protocol and the conduct or results of the Trial. However, if a joint publication is submitted for publication the individual Investigator has no right to publish results from his/her centre until such the joint publication is actually issued.
- Publication restrictions are in place
Restriction type: OTHER