Trial Outcomes & Findings for Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia. (NCT NCT03993288)
NCT ID: NCT03993288
Last Updated: 2021-07-12
Results Overview
Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups
COMPLETED
PHASE3
267 participants
Baseline and Week 12
2021-07-12
Participant Flow
Participants were enrolled from 18 sites in the Russian Federation.
Participants were randomized in 1:1 ratio to two treatment arms.
Participant milestones
| Measure |
Ferrum Lek
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
134
|
|
Overall Study
Intention-to-treat (ITT) Population
|
123
|
129
|
|
Overall Study
Safety Analysis Set
|
133
|
134
|
|
Overall Study
COMPLETED
|
123
|
129
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Ferrum Lek
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
non-compliance to the inclusion criteria
|
0
|
1
|
|
Overall Study
wrong randomization
|
0
|
1
|
|
Overall Study
improper enrollment
|
0
|
1
|
|
Overall Study
prescribed with prohibited concomitant therapy
|
1
|
0
|
|
Overall Study
developed SAE
|
2
|
0
|
|
Overall Study
consent withdrawal
|
1
|
0
|
|
Overall Study
did not follow the treatment schedule
|
1
|
0
|
|
Overall Study
did not follow the treatment regimen
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.
Baseline characteristics by cohort
| Measure |
Ferrum Lek
n=133 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=134 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.68 years
n=39 Participants
|
38.16 years
n=41 Participants
|
38.92 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=39 Participants
|
125 Participants
n=41 Participants
|
249 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
131 Participants
n=39 Participants
|
132 Participants
n=41 Participants
|
263 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in Blood Hemoglobin Level (g/L)
|
18.33 g/L
Standard Deviation 15.05
|
18.52 g/L
Standard Deviation 14.57
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8 and 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Change in average values of iron metabolism parameter serum iron during the treatment period
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in Serum Iron
Week 4
|
1.76 micromoles/liter
Standard Deviation 7.35
|
3.42 micromoles/liter
Standard Deviation 6.57
|
|
Change From Baseline in Serum Iron
Week 8
|
4.09 micromoles/liter
Standard Deviation 9.62
|
4.34 micromoles/liter
Standard Deviation 9.19
|
|
Change From Baseline in Serum Iron
Week 12
|
5.16 micromoles/liter
Standard Deviation 9.56
|
6.12 micromoles/liter
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8 and 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Change in average values of iron metabolism parameter transferrin during the treatment period
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in Transferrin
Week 4
|
-0.15 g/L
Standard Deviation 0.31
|
-0.14 g/L
Standard Deviation 0.38
|
|
Change From Baseline in Transferrin
Week 8
|
-0.22 g/L
Standard Deviation 0.41
|
-0.22 g/L
Standard Deviation 0.41
|
|
Change From Baseline in Transferrin
Week 12
|
-0.24 g/L
Standard Deviation 0.41
|
-0.25 g/L
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8 and 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in Percent Transferrin Saturation
Week 4
|
2.46 percent transferrin saturation
Standard Deviation 5.82
|
4.44 percent transferrin saturation
Standard Deviation 8.04
|
|
Change From Baseline in Percent Transferrin Saturation
Week 8
|
8.25 percent transferrin saturation
Standard Deviation 12.54
|
5.47 percent transferrin saturation
Standard Deviation 9.45
|
|
Change From Baseline in Percent Transferrin Saturation
Week 12
|
7.27 percent transferrin saturation
Standard Deviation 12.02
|
8.03 percent transferrin saturation
Standard Deviation 10.14
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8 and 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Change in average values of iron metabolism parameter ferritin during the treatment period
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Change From Baseline in Ferritin
Week 4
|
3.48 microgram/liter
Standard Deviation 11.2
|
7.35 microgram/liter
Standard Deviation 33.76
|
|
Change From Baseline in Ferritin
Week 8
|
4.9 microgram/liter
Standard Deviation 14.72
|
4.49 microgram/liter
Standard Deviation 15.42
|
|
Change From Baseline in Ferritin
Week 12
|
7.62 microgram/liter
Standard Deviation 20.24
|
6.55 microgram/liter
Standard Deviation 15.87
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intention-to-treat (ITT) population included all randomized participants who were administered at least one dose of the investigational product or comparator and who had hemoglobin level data both before and after treatment with the investigational product and the reference product.
Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment
Outcome measures
| Measure |
Ferrum Lek
n=123 Participants
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=129 Participants
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Number of Participants With Response to the Therapy
|
59 Participants
|
56 Participants
|
Adverse Events
Ferrum Lek
MALTOFER
Serious adverse events
| Measure |
Ferrum Lek
n=133 participants at risk
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=134 participants at risk
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.75%
1/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
0.00%
0/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Nervous system disorders
Encephalopathy
|
0.75%
1/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
0.00%
0/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
Other adverse events
| Measure |
Ferrum Lek
n=133 participants at risk
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
|
MALTOFER
n=134 participants at risk
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
13/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
6.7%
9/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Gastrointestinal disorders
Stool discoloration
|
19.5%
26/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
14.9%
20/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
6/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
5.2%
7/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
9/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
4.5%
6/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Gastrointestinal disorders
Nausea
|
5.3%
7/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
3.7%
5/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Nervous system disorders
Headache
|
3.8%
5/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
6.0%
8/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Gastrointestinal disorders
Constipation
|
6.0%
8/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
5.2%
7/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
4/133 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
6.0%
8/134 • Adverse Events were collected for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
Any signs or symptoms that occurred for 14 weeks (12 weeks treatment period plus 2 weeks follow up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER