Condition or disease | Intervention/treatment | Phase |
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Mild and Moderate Iron-deficiency Anaemia | Drug: Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia) Drug: MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 267 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | June 27, 2019 |
Actual Primary Completion Date : | June 18, 2020 |
Actual Study Completion Date : | June 18, 2020 |
Arm | Intervention/treatment |
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Experimental: Ferrum Lek
Patients will receive Ferrum Lek® 2 tablets daily (200 mg), during 12 weeks
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Drug: Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)
Ferrum Lek® 2 tablets daily (200 mg), during 12 weeks
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Active Comparator: MALTOFER
Patients will receive MALTOFER® 2 tablets daily (200 mg) during 12 weeks
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Drug: MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)
Patients will receive MALTOFER® 2 tablets daily (200 mg) during 12 weeks
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosed iron-deficiency anemia, based on two criteria:
Exclusion Criteria:
Other causes of anemia, apart from iron deficiency, including:
The necessity of parenteral iron therapy, i.e. the following cases:
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:
Russian Federation | |
Sandoz Investigative Site | |
Krasnogorsk, Russian Federation, 143408 | |
Sandoz Investigative Site | |
Moscow, Russian Federation, 119121 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 188643 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 191186 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 192177 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 193232 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 194354 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 194356 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 195197 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 196143 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 197706 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 198207 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 198328 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 199178 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 199226 | |
Sandoz Investigative Site | |
Saint-Petersburg, Russian Federation, 199406 | |
Sandoz Investigative Site | |
Smolensk, Russian Federation, 214019 | |
Sandoz Investigative Site | |
Yaroslavl, Russian Federation, 150003 |
Study Director: | Sandoz | Sandoz |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 18, 2019 | ||||||||
First Posted Date ICMJE | June 20, 2019 | ||||||||
Last Update Posted Date | March 5, 2021 | ||||||||
Actual Study Start Date ICMJE | June 27, 2019 | ||||||||
Actual Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change from baseline in blood haemoglobin level (g/L) [ Time Frame: Baseline and Week 12 ] Changes in blood haemoglobin 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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | 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. | ||||||||
Official Title ICMJE | 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. | ||||||||
Brief Summary | The purpose of this study is to evaluate non-inferiority 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 | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Mild and Moderate Iron-deficiency Anaemia | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
267 | ||||||||
Original Estimated Enrollment ICMJE |
336 | ||||||||
Actual Study Completion Date ICMJE | June 18, 2020 | ||||||||
Actual Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Russian Federation | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03993288 | ||||||||
Other Study ID Numbers ICMJE | TE_005_FER_CHT | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sandoz | ||||||||
Study Sponsor ICMJE | Sandoz | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Sandoz | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |