Iron Deficiency Anemia
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGFerric 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.
DRUGIron 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.
Sponsors
Tigermed Consulting Co., Ltd
Vifor (International) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Hb \<11 g/dL (females) or Hb \<12 g/dL (males) at the screening visit * Serum ferritin \<100 ng/mL for subjects with underlying inflammatory disease (e.g., inflammatory bowel disease (IBD), chronic kidney disease (CKD) or chronic heart failure (CHF), as determined by high sensitive C-reactive protein \[hsCRP\] levels above the normal range) otherwise ≤14 ng/mL in subjects with no apparent underlying inflammatory disease (as determined by hsCRP levels within normal range) at the screening visit * Transferrin Saturation (TSAT) \<16% (any subject) at the screening visit * Microcytic, hypochromic anaemia defined as: a) Mean corpuscular Hb concentration (MCHC) \<32%; b) Mean corpuscular volume (MCV) \< 80 fL; c)Mean corpuscular Hb (MCH) \<27 pg * Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments * Before any study-specific procedure is conducted, the appropriate written informed consent must be obtained
Exclusion criteria
* Subject has known hypersensitivity to any of the products to be administered during dosing * Any history of iron storage diseases such as haemochromatosis * Any history or clinical findings of iron utilisation disorders such as sideroachrestic anaemia * Known haemoglobinopathy (e.g. thalassaemia) * Any history or clinical findings of anaemia associated with: a) Haematuria b) Vitamin B12 or folic acid deficiency that requires treatment (subjects can be included after deficiency is corrected) * Any allergic predispositions, i.e. any history of asthma or atopic allergy. This includes drug allergies. * Planned surgery with anticipated blood loss (defined as Hb drop \>2 g/dL) in the 3 months post randomisation * Subject has known malignancy (with or without current treatment), except basal cell or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia * Haemodialysis (current or planned within the next 3 months) * History of IV iron therapy, erythropoiesis stimulating agent (ESA) therapy and/or blood transfusion in previous 4 weeks prior to screening, and oral iron or oral iron-containing products including Chinese herbal medicines (\>75mg iron/day) in the 7 days prior to screening * Body weight \<35 kg * Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above 3 times the upper limit of the normal range * Known human immunodeficiency virus infection, acquired immunodeficiency syndrome, tuberculosis * Known active hepatitis B or C or other active infection (acute or chronic) * Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s) * Subject is pregnant or is breast feeding * Female subject of childbearing potential not using adequate contraceptive methods during the study and for up to 1 month after the last dose of the study medication. Adequate contraceptive methods are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhoea for at least 12 months * Male subjects planning to father a child within 7 days from the last study drug administration. * Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures and/or other reason(s) that render subject not appropriate for study participation in the opinion of the treating physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 | From baseline at any time up to Week 8 | Haemoglobin (Hb) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | From Baseline to weeks 2, 4, 6 and 8 | Haemoglobin (Hb) |
| Participants With Iron Deficiency Correction Over Time by Treatment | From Baseline to Weeks 2, 4, 6 and 8 | 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). |
| Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to weeks 2, 4, 6 and 8 | Transferrin saturation (TSAT) |
| Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to Weeks 2, 4, 6 and 8 | — |
| Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to weeks 2, 4, 6 and 8 | — |
| Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | From Baseline to weeks 2, 4, 6 and 8 | Haemoglobin (Hb) |
| Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Baseline and weeks 2, 4, 6 and 8 | Diastolic Blood pressure |
| Body Weight at Baseline and Week 8 | Baseline and week 8 | — |
| Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Baseline and weeks 2, 4, 6 and 8 | — |
| Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Baseline and weeks 2, 4, 6 and 8 | — |
| Participants With Any Treatment Emergent Adverse Event (TEAE) | From Baseline to the End of the study (week 8) | 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 |
Countries
China
Participant flow
Pre-assignment details
Subjects who provided signed and dated informed consent were screened within 7 days prior to initial treatment administration.
Participants by arm
| Arm | Count |
|---|---|
| Ferric Carboxymaltose (FCM) Participants treated with FCM given by IV injection or drip infusion
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. | 187 |
| Iron Sucrose (IS) Participants treated with IS given by IV injection or drip infusion
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. | 180 |
| Total | 367 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Iron Sucrose (IS) | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 8.7 | 39.9 years STANDARD_DEVIATION 9.85 | 39.4 years STANDARD_DEVIATION 9.31 |
| Haemoglobin | 8.06 g/dl STANDARD_DEVIATION 1.453 | 7.74 g/dl STANDARD_DEVIATION 1.491 | 7.90 g/dl STANDARD_DEVIATION 1.479 |
| High-sensitivity C-reactive protein (hsCRP) | 1.567 mg/l STANDARD_DEVIATION 5.9817 | 1.026 mg/l STANDARD_DEVIATION 2.1432 | 1.291 mg/l STANDARD_DEVIATION 4.4617 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 180 Participants | 187 Participants | 367 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 180 Participants | 187 Participants | 367 Participants |
| Serum ferritin | 4.93 ng/ml STANDARD_DEVIATION 6.095 | 4.47 ng/ml STANDARD_DEVIATION 2.145 | 4.70 ng/ml STANDARD_DEVIATION 4.534 |
| Sex: Female, Male Female | 169 Participants | 173 Participants | 342 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
| Transferrin saturation (TSAT) | 4.92 % STANDARD_DEVIATION 2.912 | 4.82 % STANDARD_DEVIATION 1.898 | 4.87 % STANDARD_DEVIATION 2.446 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 187 | 0 / 180 |
| other Total, other adverse events | 124 / 187 | 92 / 180 |
| serious Total, serious adverse events | 10 / 187 | 7 / 180 |
Outcome results
Primary
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
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 | 176 Participants |
| Iron Sucrose (IS) | Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 | 175 Participants |
95% CI: [-2.15, 4.71]
Secondary
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8
Diastolic Blood pressure
Time frame: Baseline and weeks 2, 4, 6 and 8
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 71.0 mmHg | Standard Deviation 8.33 |
| Ferric Carboxymaltose (FCM) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 71.6 mmHg | Standard Deviation 8.18 |
| Ferric Carboxymaltose (FCM) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 72.1 mmHg | Standard Deviation 7.6 |
| Ferric Carboxymaltose (FCM) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 72.4 mmHg | Standard Deviation 8.09 |
| Ferric Carboxymaltose (FCM) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 69.8 mmHg | Standard Deviation 7.91 |
| Iron Sucrose (IS) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 74.1 mmHg | Standard Deviation 9.77 |
| Iron Sucrose (IS) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 71.9 mmHg | Standard Deviation 8.85 |
| Iron Sucrose (IS) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 72.6 mmHg | Standard Deviation 8.79 |
| Iron Sucrose (IS) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 73.8 mmHg | Standard Deviation 9.57 |
| Iron Sucrose (IS) | Blood Pressure at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 74.3 mmHg | Standard Deviation 9.24 |
Secondary
Body Temperature at Baseline and Weeks 2, 4, 6 and 8
Time frame: Baseline and weeks 2, 4, 6 and 8
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 36.48 ºC | Standard Deviation 0.269 |
| Ferric Carboxymaltose (FCM) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 36.94 ºC | Standard Deviation 0.292 |
| Ferric Carboxymaltose (FCM) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 36.48 ºC | Standard Deviation 0.269 |
| Ferric Carboxymaltose (FCM) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 36.49 ºC | Standard Deviation 0.269 |
| Ferric Carboxymaltose (FCM) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 36.47 ºC | Standard Deviation 0.259 |
| Iron Sucrose (IS) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 36.41 ºC | Standard Deviation 0.26 |
| Iron Sucrose (IS) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 36.40 ºC | Standard Deviation 0.268 |
| Iron Sucrose (IS) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 36.45 ºC | Standard Deviation 0.325 |
| Iron Sucrose (IS) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 36.46 ºC | Standard Deviation 0.257 |
| Iron Sucrose (IS) | Body Temperature at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 36.44 ºC | Standard Deviation 0.288 |
Secondary
Body Weight at Baseline and Week 8
Time frame: Baseline and week 8
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Body Weight at Baseline and Week 8 | Baseline | 59.76 kg | Standard Deviation 9.384 |
| Ferric Carboxymaltose (FCM) | Body Weight at Baseline and Week 8 | Week 8 | 59.73 kg | Standard Deviation 9.316 |
| Iron Sucrose (IS) | Body Weight at Baseline and Week 8 | Baseline | 60.40 kg | Standard Deviation 9.354 |
| Iron Sucrose (IS) | Body Weight at Baseline and Week 8 | Week 8 | 60.64 kg | Standard Deviation 9.372 |
Secondary
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
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 6 | 4.96 g/dL | Standard Deviation 1.435 |
| Ferric Carboxymaltose (FCM) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 4 | 4.46 g/dL | Standard Deviation 1.502 |
| Ferric Carboxymaltose (FCM) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 8 | 5.09 g/dL | Standard Deviation 1.504 |
| Ferric Carboxymaltose (FCM) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 2 | 3.01 g/dL | Standard Deviation 1.135 |
| Iron Sucrose (IS) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 8 | 4.87 g/dL | Standard Deviation 1.525 |
| Iron Sucrose (IS) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 6 | 4.61 g/dL | Standard Deviation 1.422 |
| Iron Sucrose (IS) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 2 | 2.53 g/dL | Standard Deviation 1.016 |
| Iron Sucrose (IS) | Change in Hb From Baseline to Weeks 2, 4, 6, and 8 | Week 4 | 4.08 g/dL | Standard Deviation 1.217 |
Secondary
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8
Time frame: From Baseline to Weeks 2, 4, 6 and 8
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 759.72 ng/ml | Standard Deviation 331.118 |
| Ferric Carboxymaltose (FCM) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 379.31 ng/ml | Standard Deviation 195.415 |
| Ferric Carboxymaltose (FCM) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 255.71 ng/ml | Standard Deviation 152.582 |
| Ferric Carboxymaltose (FCM) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 202.09 ng/ml | Standard Deviation 148.382 |
| Iron Sucrose (IS) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 145.56 ng/ml | Standard Deviation 89.89 |
| Iron Sucrose (IS) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 385.51 ng/ml | Standard Deviation 145.647 |
| Iron Sucrose (IS) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 184.93 ng/ml | Standard Deviation 100.677 |
| Iron Sucrose (IS) | Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 280.58 ng/ml | Standard Deviation 148.913 |
Secondary
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8
Time frame: From Baseline to weeks 2, 4, 6 and 8
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 15.53 umol/L | Standard Deviation 7.075 |
| Ferric Carboxymaltose (FCM) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 12.31 umol/L | Standard Deviation 4.209 |
| Ferric Carboxymaltose (FCM) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 10.77 umol/L | Standard Deviation 4.318 |
| Ferric Carboxymaltose (FCM) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 10.77 umol/L | Standard Deviation 4.871 |
| Iron Sucrose (IS) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 10.09 umol/L | Standard Deviation 4.152 |
| Iron Sucrose (IS) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 16.23 umol/L | Standard Deviation 14.512 |
| Iron Sucrose (IS) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 11.27 umol/L | Standard Deviation 4.16 |
| Iron Sucrose (IS) | Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 12.39 umol/L | Standard Deviation 4.724 |
Secondary
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
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 30.16 Percentage of TSAT | Standard Deviation 11.741 |
| Ferric Carboxymaltose (FCM) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 28.00 Percentage of TSAT | Standard Deviation 8.528 |
| Ferric Carboxymaltose (FCM) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 25.50 Percentage of TSAT | Standard Deviation 9.097 |
| Ferric Carboxymaltose (FCM) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 25.32 Percentage of TSAT | Standard Deviation 10.793 |
| Iron Sucrose (IS) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 20.82 Percentage of TSAT | Standard Deviation 7.618 |
| Iron Sucrose (IS) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 25.03 Percentage of TSAT | Standard Deviation 19.474 |
| Iron Sucrose (IS) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 23.33 Percentage of TSAT | Standard Deviation 7.868 |
| Iron Sucrose (IS) | Change in TSAT From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 25.30 Percentage of TSAT | Standard Deviation 8.453 |
Secondary
Heart Rate at Baseline and Weeks 2, 4, 6 and 8
Time frame: Baseline and weeks 2, 4, 6 and 8
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 76.3 beats/min | Standard Deviation 9.8 |
| Ferric Carboxymaltose (FCM) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 76.0 beats/min | Standard Deviation 8.98 |
| Ferric Carboxymaltose (FCM) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 75.5 beats/min | Standard Deviation 10.71 |
| Ferric Carboxymaltose (FCM) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 75.8 beats/min | Standard Deviation 10.33 |
| Ferric Carboxymaltose (FCM) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 81.4 beats/min | Standard Deviation 8.85 |
| Iron Sucrose (IS) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 8 | 77.5 beats/min | Standard Deviation 10.94 |
| Iron Sucrose (IS) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Baseline | 82.2 beats/min | Standard Deviation 9.94 |
| Iron Sucrose (IS) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 2 | 76.5 beats/min | Standard Deviation 8.83 |
| Iron Sucrose (IS) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 4 | 76.6 beats/min | Standard Deviation 10.79 |
| Iron Sucrose (IS) | Heart Rate at Baseline and Weeks 2, 4, 6 and 8 | Week 6 | 77.2 beats/min | Standard Deviation 10.04 |
Secondary
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
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 150 Participants |
| Ferric Carboxymaltose (FCM) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 164 Participants |
| Ferric Carboxymaltose (FCM) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 169 Participants |
| Ferric Carboxymaltose (FCM) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 173 Participants |
| Iron Sucrose (IS) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 8 | 171 Participants |
| Iron Sucrose (IS) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 2 | 129 Participants |
| Iron Sucrose (IS) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 6 | 168 Participants |
| Iron Sucrose (IS) | Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8 | Week 4 | 167 Participants |
Secondary
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)
Population: Safety Set: all randomised participants who have received at least 1 dose of study medication. The participants in this group were analysed based on the treatment they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Participants With Any Treatment Emergent Adverse Event (TEAE) | 124 Participants |
| Iron Sucrose (IS) | Participants With Any Treatment Emergent Adverse Event (TEAE) | 101 Participants |
Secondary
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
Population: Per Protocol Set: participants who were randomised, received at least 1 dose of study treatment, had at least 1 baseline and post-baseline value (Hb, ferritin, TSAT), had a study drug compliance between 80% and 120% and had no major protocol violations
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 2 | 173 Participants |
| Ferric Carboxymaltose (FCM) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 4 | 165 Participants |
| Ferric Carboxymaltose (FCM) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 6 | 161 Participants |
| Ferric Carboxymaltose (FCM) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 8 | 162 Participants |
| Iron Sucrose (IS) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 8 | 154 Participants |
| Iron Sucrose (IS) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 2 | 135 Participants |
| Iron Sucrose (IS) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 6 | 163 Participants |
| Iron Sucrose (IS) | Participants With Iron Deficiency Correction Over Time by Treatment | Week 4 | 168 Participants |