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出境医 / 临床实验 / 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 Iro

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 Iro

Study Description
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.

Condition or disease Intervention/treatment Phase
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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Ferrum Lek
Patients will receive Ferrum Lek® 2 tablets daily (200 mg), during 12 weeks
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

Active Comparator: MALTOFER
Patients will receive MALTOFER® 2 tablets daily (200 mg) during 12 weeks
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

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from baseline in ferritin [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter ferritin during the treatment period

  2. Change from baseline in transferrin [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter transferrin during the treatment period

  3. Change from baseline in percent transferrin saturation [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period

  4. Change from baseline in serum iron [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter serum iron during the treatment period

  5. Percentage of subjects with response to the therapy [ Time Frame: Baseline and Week 12 ]
    Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The signed and dated written informed consent prior to participation in the study.
  2. Men and women aged 18 and older (by the time of screening).
  3. Outpatients.
  4. Diagnosed iron-deficiency anemia, based on two criteria:

    1. hemoglobin level below 110 g/L (in men and women), but above 80 g/L,
    2. serum ferritin levels below 30 µg/L.

Exclusion Criteria:

  1. Administration of any iron-containing drugs during the last 3 months.
  2. History of erythropoietin drugs administration.
  3. Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
  4. 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.
  5. History of severe allergic reactions or drug intolerance.
  6. Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency.
  7. Pregnant or lactating women, or women intending to become pregnant during the study.
  8. Failure of iron therapy for iron-deficiency anaemia in a subject's past medical history.
  9. Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassaemia).
  10. Iron overload including haemochromatosis and hemosiderosis
  11. Other causes of anemia, apart from iron deficiency, including:

    1. Haemolysis (determined as per analyses results at screening, or as per anamnestic data),
    2. Vitamin B12 and folic acid deficiency (as per the screening data),
    3. Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)),
    4. 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.
  12. Dysfunction of the thyroid gland (based on the data obtained at screening).
  13. Laboratory and clinical signs of an active inflammatory process for 10 days before screening.
  14. AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more.
  15. Clinically apparent hypothyroidism, in the investigator's opinion.
  16. 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.
  17. Signs of bone marrow aplasia at screening or history of bone marrow aplasia.
  18. The necessity of parenteral iron therapy, i.e. the following cases:

    1. impaired absorption in case of an intestinal pathology (enteritis, coeliac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum);
    2. exacerbation of gastric or duodenal ulcer;
    3. the necessity of quick iron saturation, e.g. in patients with iron-deficiency anaemia with upcoming surgery;
    4. continuous vast blood loss and other causes, at the discretion of the investigator.
  19. 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.
  20. 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:

    1. Myocardial infarction or stroke within 6 months before screening.
    2. Unstable angina;
    3. Severe arrhythmia, not controlled by drug therapy;
    4. Decompensated diabetes mellitus;
    5. Nephrological disorders;
    6. Other significant diseases, at the discretion of the investigator.
  21. HIV infection (as per the screening data or the results of analysis performed within 6 months before screening).
  22. Known or suspected drug or alcohol abuse for the last 2 years.
  23. Suspected poor adherence of a subject (e.g., due to mental disorders).
  24. Participation in any clinical drug studies less than 3 months before the study.
  25. Blood donation / blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening.
  26. History of smoking, unless leave off smoking > 6 months.
Contacts and Locations

Locations
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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
Sponsors and Collaborators
Sandoz
Investigators
Layout table for investigator information
Study Director: Sandoz Sandoz
Tracking Information
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
 (submitted: June 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change from baseline in ferritin [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter ferritin during the treatment period
  • Change from baseline in transferrin [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter transferrin during the treatment period
  • Change from baseline in percent transferrin saturation [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period
  • Change from baseline in serum iron [ Time Frame: Baseline and Week 12 ]
    Change in average values of iron metabolism parameter serum iron during the treatment period
  • Percentage of subjects with response to the therapy [ Time Frame: Baseline and Week 12 ]
    Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment
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
Condition  ICMJE Mild and Moderate Iron-deficiency Anaemia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Ferrum Lek
    Patients will receive Ferrum Lek® 2 tablets daily (200 mg), during 12 weeks
    Intervention: Drug: Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)
  • Active Comparator: MALTOFER
    Patients will receive MALTOFER® 2 tablets daily (200 mg) during 12 weeks
    Intervention: Drug: MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2021)
267
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
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:

  1. The signed and dated written informed consent prior to participation in the study.
  2. Men and women aged 18 and older (by the time of screening).
  3. Outpatients.
  4. Diagnosed iron-deficiency anemia, based on two criteria:

    1. hemoglobin level below 110 g/L (in men and women), but above 80 g/L,
    2. serum ferritin levels below 30 µg/L.

Exclusion Criteria:

  1. Administration of any iron-containing drugs during the last 3 months.
  2. History of erythropoietin drugs administration.
  3. Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
  4. 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.
  5. History of severe allergic reactions or drug intolerance.
  6. Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency.
  7. Pregnant or lactating women, or women intending to become pregnant during the study.
  8. Failure of iron therapy for iron-deficiency anaemia in a subject's past medical history.
  9. Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassaemia).
  10. Iron overload including haemochromatosis and hemosiderosis
  11. Other causes of anemia, apart from iron deficiency, including:

    1. Haemolysis (determined as per analyses results at screening, or as per anamnestic data),
    2. Vitamin B12 and folic acid deficiency (as per the screening data),
    3. Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)),
    4. 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.
  12. Dysfunction of the thyroid gland (based on the data obtained at screening).
  13. Laboratory and clinical signs of an active inflammatory process for 10 days before screening.
  14. AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more.
  15. Clinically apparent hypothyroidism, in the investigator's opinion.
  16. 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.
  17. Signs of bone marrow aplasia at screening or history of bone marrow aplasia.
  18. The necessity of parenteral iron therapy, i.e. the following cases:

    1. impaired absorption in case of an intestinal pathology (enteritis, coeliac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum);
    2. exacerbation of gastric or duodenal ulcer;
    3. the necessity of quick iron saturation, e.g. in patients with iron-deficiency anaemia with upcoming surgery;
    4. continuous vast blood loss and other causes, at the discretion of the investigator.
  19. 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.
  20. 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:

    1. Myocardial infarction or stroke within 6 months before screening.
    2. Unstable angina;
    3. Severe arrhythmia, not controlled by drug therapy;
    4. Decompensated diabetes mellitus;
    5. Nephrological disorders;
    6. Other significant diseases, at the discretion of the investigator.
  21. HIV infection (as per the screening data or the results of analysis performed within 6 months before screening).
  22. Known or suspected drug or alcohol abuse for the last 2 years.
  23. Suspected poor adherence of a subject (e.g., due to mental disorders).
  24. Participation in any clinical drug studies less than 3 months before the study.
  25. Blood donation / blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening.
  26. History of smoking, unless leave off smoking > 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Access Criteria: This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
URL: https://clinicalstudydatarequest.com/
Responsible Party Sandoz
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sandoz Sandoz
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

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