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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
267
Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
Sandoz Investigative Site
Krasnogorsk, Russia
Sandoz Investigative Site
Moscow, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
...and 8 more locations
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
Time frame: Baseline and Week 12
Change From Baseline in Serum Iron
Change in average values of iron metabolism parameter serum iron during the treatment period
Time frame: Baseline, Week 4, 8 and 12
Change From Baseline in Transferrin
Change in average values of iron metabolism parameter transferrin during the treatment period
Time frame: 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
Time frame: Baseline, Week 4, 8 and 12
Change From Baseline in Ferritin
Change in average values of iron metabolism parameter ferritin during the treatment period
Time frame: 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
Time frame: Baseline and Week 12
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