Mild and Moderate Iron-deficiency AnaemiaPhase 3NCT03993288
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.
A Phase 3 study testing Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) and MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) in people with Mild and Moderate Iron-deficiency Anaemia, run by Sandoz at 18 sites in Russia.
Trial summary
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland), in the treatment of patients with mild and moderate iron-deficiency anaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild and Moderate Iron-deficiency Anaemia
- What is being tested?
- Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) and MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 18 sitesRussia
- Study dates
- 27 Jun 2019to 18 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The signed and dated written informed consent prior to participation in the study.
- Men and women aged 18 and older (by the time of screening).
- Outpatients.
- Diagnosed iron-deficiency anemia, based on two criteria:
- hemoglobin level below 110 g/L (in men and women), but above 80 g/L,
- serum ferritin levels below 30 µg/L.
Who cannot join
- Administration of any iron-containing drugs during the last 3 months.
- History of erythropoietin drugs administration.
- Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
- Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study.
- History of severe allergic reactions or drug intolerance.
- Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency.
Show all 40Show fewer
- Pregnant or lactating women, or women intending to become pregnant during the study.
- Failure of iron therapy for iron-deficiency anaemia in a subject's past medical history.
- Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassaemia).
- Iron overload including haemochromatosis and hemosiderosis
- Other causes of anemia, apart from iron deficiency, including:
- Haemolysis (determined as per analyses results at screening, or as per anamnestic data),
- Vitamin B12 and folic acid deficiency (as per the screening data),
- Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)),
- Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy (as per the past medical history), and other conditions which may, in the investigator's opinion, be accompanied by anaemia of chronic diseases.
- Dysfunction of the thyroid gland (based on the data obtained at screening).
- Laboratory and clinical signs of an active inflammatory process for 10 days before screening.
- AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more.
- Clinically apparent hypothyroidism, in the investigator's opinion.
- Malignant diseases, including blood and lymphoid tissue disorders (leukemia, Hodgkin disease, myelodysplastic syndrome, myeloma, etc.) at screening or in the past medical history, provided that the remission was less than 5 years before screening.
- Signs of bone marrow aplasia at screening or history of bone marrow aplasia.
- The necessity of parenteral iron therapy, i.e. the following cases:
- impaired absorption in case of an intestinal pathology (enteritis, coeliac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum);
- exacerbation of gastric or duodenal ulcer;
- the necessity of quick iron saturation, e.g. in patients with iron-deficiency anaemia with upcoming surgery;
- continuous vast blood loss and other causes, at the discretion of the investigator.
- Known presence of an active infection caused by Helicobacter pylori. In case of presence of Helicobacter pylori, a subject may be enrolled after eradicative therapy.
- Concomitant diseases and conditions, which, in the investigator's opinion, pose risk to a subject's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study, including:
- Myocardial infarction or stroke within 6 months before screening.
- Unstable angina;
- Severe arrhythmia, not controlled by drug therapy;
- Decompensated diabetes mellitus;
- Nephrological disorders;
- Other significant diseases, at the discretion of the investigator.
- HIV infection (as per the screening data or the results of analysis performed within 6 months before screening).
- Known or suspected drug or alcohol abuse for the last 2 years.
- Suspected poor adherence of a subject (e.g., due to mental disorders).
- Participation in any clinical drug studies less than 3 months before the study.
- Blood donation / blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening.
- History of smoking, unless leave off smoking > 6 months.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Sandoz Investigative Site
Krasnogorsk, 143408
Sandoz Investigative Site
Moscow, 119121
Sandoz Investigative Site
Saint Petersburg, 188643
Sandoz Investigative Site
Saint Petersburg, 191186
Sandoz Investigative Site
Saint Petersburg, 192177
Sandoz Investigative Site
Saint Petersburg, 193232
Sandoz Investigative Site
Saint Petersburg, 194354
Sandoz Investigative Site
Saint Petersburg, 194356
Sandoz Investigative Site
Saint Petersburg, 195197
Sandoz Investigative Site
Saint Petersburg, 196143
Sandoz Investigative Site
Saint Petersburg, 197706
Sandoz Investigative Site
Saint Petersburg, 198207
Sandoz Investigative Site
Saint Petersburg, 198328
Sandoz Investigative Site
Saint Petersburg, 199178
Sandoz Investigative Site
Saint Petersburg, 199226
Sandoz Investigative Site
Saint Petersburg, 199406
Sandoz Investigative Site
Smolensk, 214019
Sandoz Investigative Site
Yaroslavl, 150003
About this study
Official title: Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Vifor S.A., Switzerland), in Treatment of Patients With Mild and Moderate Iron-deficiency Anaemia.
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland), in the treatment of patients with mild and moderate iron-deficiency anaemia.
Read the detailed description
This was a multi-centric, open-label, randomized, prospective, comparative, parallel-group, active-controlled, phase III clinical trial (in the Russian Federation).
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), compared to MALTOFER®, in the treatment of patients with mild and moderate iron-deficiency anaemia.
Participants underwent screening for up to 7 days. Eligible participants were randomized in 1:1 ratio to two treatment arms.
Subjects in Group 1 received 2 tablets per day (200 mg) of chewable tablets Ferrum Lek® during or immediately after meals; once daily.
Subjects in Group 2 (reference product) received 2 tablets per day (200 mg) of chewable tablets Maltofer® during or immediately after meals; once daily.
The subjects received the medicinal products daily for 12 weeks. After the last scheduled study site visit, a follow-up visit (by phone) was scheduled 14 days after the completion of the active treatment period (day 98±2) to record any delayed adverse events.
- Being tested
- Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)
- Keywords
- Ferrum Lek® (iron (III) hydroxide polymaltosate), mild and moderate iron-deficiency anaemia
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)Drug
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)Drug
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ferrum Lek | Experimental | Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks Receives: Drug: Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) |
| MALTOFER | Active comparator | Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks Receives: Drug: MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Hemoglobin Level (g/L)
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
Measured: Baseline and Week 12
Secondary outcomes (5)
Change From Baseline in Serum Iron
Change in average values of iron metabolism parameter serum iron during the treatment period
Measured: Baseline, Week 4, 8 and 12
Change From Baseline in Transferrin
Change in average values of iron metabolism parameter transferrin during the treatment period
Measured: Baseline, Week 4, 8 and 12
Change From Baseline in Percent Transferrin Saturation
Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period
Measured: Baseline, Week 4, 8 and 12
Change From Baseline in Ferritin
Change in average values of iron metabolism parameter ferritin during the treatment period
Measured: Baseline, Week 4, 8 and 12
Number of Participants With Response to the Therapy
Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start27 Jun 2019
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild and Moderate Iron-deficiency AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993288
- Sponsor's protocol ID
- TE_005_FER_CHT
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2019
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Vifor S.A., Switzerland), in Treatment of Patients With Mild and Moderate Iron-deficiency Anaemia.
- ClinicalTrials.gov ID
- NCT03993288
- Acronym / sponsor ID
- TE_005_FER_CHT
- Keywords
- Ferrum Lek® (iron (III) hydroxide polymaltosate), mild and moderate iron-deficiency anaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 12 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland), in the treatment of patients with mild and moderate iron-deficiency anaemia.
Detailed description
This was a multi-centric, open-label, randomized, prospective, comparative, parallel-group, active-controlled, phase III clinical trial (in the Russian Federation).
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), compared to MALTOFER®, in the treatment of patients with mild and moderate iron-deficiency anaemia.
Participants underwent screening for up to 7 days. Eligible participants were randomized in 1:1 ratio to two treatment arms.
Subjects in Group 1 received 2 tablets per day (200 mg) of chewable tablets Ferrum Lek® during or immediately after meals; once daily.
Subjects in Group 2 (reference product) received 2 tablets per day (200 mg) of chewable tablets Maltofer® during or immediately after meals; once daily.
The subjects received the medicinal products daily for 12 weeks. After the last scheduled study site visit, a follow-up visit (by phone) was scheduled 14 days after the completion of the active treatment period (day 98±2) to record any delayed adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrum Lek | Experimental | Drug: Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks |
| MALTOFER | Active comparator | Drug: MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The signed and dated written informed consent prior to participation in the study.
- Men and women aged 18 and older (by the time of screening).
- Outpatients.
- Diagnosed iron-deficiency anemia, based on two criteria:
Key exclusion criteria (40 listed)
- Administration of any iron-containing drugs during the last 3 months.
- History of erythropoietin drugs administration.
- Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
- Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study.
- History of severe allergic reactions or drug intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks | Drug | Ferrum Lek |
| MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks | Drug | MALTOFER |
Primary outcome
Change From Baseline in Blood Hemoglobin Level (g/L)
Time frame: Baseline and Week 12
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
5 secondary outcomes
Change From Baseline in Serum Iron
Time frame: Baseline, Week 4, 8 and 12
Change From Baseline in Transferrin
Time frame: Baseline, Week 4, 8 and 12
Change From Baseline in Percent Transferrin Saturation
Time frame: Baseline, Week 4, 8 and 12
Change From Baseline in Ferritin
Time frame: Baseline, Week 4, 8 and 12
Number of Participants With Response to the Therapy
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz study director
Sandoz
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) and MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) in people with Mild and Moderate Iron-deficiency Anaemia, run by Sandoz at 18 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Blood Hemoglobin Level (g/L) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.