The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently approved intravenous (IV) iron therapy of iron sucrose (IS, Venofer™) in the Chinese population. The secondary objectives are to assess the safety of FCM compared to IS in the Chinese population and to evaluate the effect of FCM compared to IS on relevant laboratory parameters (haematology, chemistry, iron parameters) in the Chinese population.
This is an open-label, randomised controlled study to assess the impact of FCM in correcting iron deficiency anaemia compared with Venofer™ (IS). All subjects, after providing written informed consent and meeting the eligibility assessments, will receive a first dose of IV iron as either FCM or IS. A total of approximately 368 subjects (184 per group) will be enrolled. All subjects will have iron deficiency anaemia as measured by haemoglobin (Hb), serum ferritin and transferrin saturation (TSAT) at screening. Ferric carboxymaltose will be administered as either a diluted infusion or undiluted injection (at Investigator discretion) and IS will be administered as a slow intravenous injection at a rate of 1 ml undiluted solution per minute (with each single injection of 200 mg iron) or by drip infusion. Note, for subjects randomised to receive IS dosing visits are required three times a week to achieve total iron repletion dosing as calculated using the Ganzoni formula. For subjects randomised to FCM, the total iron requirements will be calculated at screening based on the screening Hb and subject weight. Dosing will be at baseline and, if required, at day 8 and day 15. All subjects will attend study visits at screening, baseline and thereafter at Weeks 2, 4 and 6. All subjects will attend an end of study visit (at Week 8 - or earlier if discontinued prematurely).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
371
Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.
Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit \[mg\] = BW \[kg\] x (target Hb- actual Hb) \[g/dL\] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
Haemoglobin (Hb)
Time frame: From baseline at any time up to Week 8
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8
Haemoglobin (Hb)
Time frame: From Baseline to weeks 2, 4, 6 and 8
Change in Hb From Baseline to Weeks 2, 4, 6, and 8
Haemoglobin (Hb)
Time frame: From Baseline to weeks 2, 4, 6 and 8
Participants With Iron Deficiency Correction Over Time by Treatment
Iron deficiency correction: TSAT \>= 16% and serum ferritin \>=100ng/mL (for subjects with underlying inflammatory disease) or \>14ng/mL (for subjects with no apparent underlying inflammatory disease).
Time frame: From Baseline to Weeks 2, 4, 6 and 8
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8
Transferrin saturation (TSAT)
Time frame: From Baseline to weeks 2, 4, 6 and 8
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8
Time frame: From Baseline to Weeks 2, 4, 6 and 8
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8
Time frame: From Baseline to weeks 2, 4, 6 and 8
Participants With Any Treatment Emergent Adverse Event (TEAE)
Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participant, in particular, the number of participants with at least one TEAE until end of the trial. Please refer to the detailed tables included on the Adverse Event Module for specifics
Time frame: From Baseline to the End of the study (week 8)
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8
Diastolic Blood pressure
Time frame: Baseline and weeks 2, 4, 6 and 8
Body Weight at Baseline and Week 8
Time frame: Baseline and week 8
Heart Rate at Baseline and Weeks 2, 4, 6 and 8
Time frame: Baseline and weeks 2, 4, 6 and 8
Body Temperature at Baseline and Weeks 2, 4, 6 and 8
Time frame: Baseline and weeks 2, 4, 6 and 8
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