To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
|ClinicalTrials.gov Identifier: NCT03591406|
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Drug: Ferric carboxymaltose Drug: Iron sucrose||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||368 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomised Controlled Multi-centre Study to Assess the Impact of Ferric Carboxymaltose in Correcting Iron Deficiency Anaemia Compared With Venofer® (Iron Sucrose) in Chinese Subjects|
|Actual Study Start Date :||July 3, 2017|
|Actual Primary Completion Date :||February 25, 2019|
|Actual Study Completion Date :||February 25, 2019|
Experimental: Ferric carboxymaltose (FCM)
Subjects treated with FCM given by IV injection or drip infusion
Drug: Ferric carboxymaltose
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.
Other Name: FCM
Active Comparator: Iron sucrose (IS)
Subjects treated with IS given by IV injection or drip infusion
Drug: Iron sucrose
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.
- Haemoglobin (Hb) g/dL [ Time Frame: From baseline at any time up to Week 8 ]Percentage of subjects achieving an increase in Hb of > or equal to 2 g/dL at any time up to week 8
- Haemoglobin (Hb) g/dL [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Percentage of subjects achieving an increase in Hb > or equal to 2 g/dL from baseline and week 2, 4, 6 and 8
- Change in Hb g/dL from baseline [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]To weeks 2, 4, 6 and 8
- Percentage of subjects with TSAT ≥16% and serum ferritin ≥100 ng/mL [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]The percentage of subjects with TSAT≥16% and serum ferritin ≥100 ng/mL (for subjects with underlying inflammatory disease as determined by hsCRP levels above the normal range) or > 14ng/mL (in subjects with no apparent underlying inflammatory disease as determined by hsCRP levels within normal range at screening) at week 2, 4, 6 and 8
- TSAT (%) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Change in TSAT from baseline to weeks 2, 4, 6 and 8
- Serum ferritin (ng/mL) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Change in serum ferritin from baseline to Weeks 2, 4, 6 and 8
- Serum iron (mcg/dL) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Change in serum iron from baseline to Weeks 2, 4, 6 and 8
- Treatment emergent adverse events (TEAE): [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Reported TEAEs
- Blood pressure (BP, mm hg) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]BP at baseline and weeks 2, 4, 6 and 8
- Body weight (BW) [ Time Frame: Baseline and week 8 ]BW
- Heart rate (beats per minute) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Heart rate
- Temperature (°C) [ Time Frame: Baseline and weeks 2, 4, 6 and 8 ]Body temperature
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591406
|The First Affiliated Hospital, Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||Jie Jin||The First Affiliated Hospital, Zhejiang University|