Iron Deficiency AnemiaPhase 3NCT03591406
To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
A Phase 3 study testing Ferric carboxymaltose and Iron sucrose in people with Iron Deficiency Anemia, run by Vifor (International) Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferric carboxymaltose and Iron sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2017to 25 Feb 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
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
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.
Read the 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).
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferric carboxymaltose, Iron sucrose
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called FCM
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.
Iron sucroseDrug
Also called IS, Venofer™
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.
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose (FCM) | Experimental | Subjects treated with FCM given by IV injection or drip infusion Receives: Drug: Ferric carboxymaltose |
| Iron sucrose (IS) | Active comparator | Subjects treated with IS given by IV injection or drip infusion Receives: Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
Haemoglobin (Hb)
Measured: From baseline at any time up to Week 8
Secondary outcomes (11)
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8
Haemoglobin (Hb)
Measured: From Baseline to weeks 2, 4, 6 and 8
Change in Hb From Baseline to Weeks 2, 4, 6, and 8
Haemoglobin (Hb)
Measured: 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).
Measured: From Baseline to Weeks 2, 4, 6 and 8
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8
Transferrin saturation (TSAT)
Measured: From Baseline to weeks 2, 4, 6 and 8
Change in Serum Ferritin From Baseline to Weeks 2, 4, 6 and 8
Measured: From Baseline to Weeks 2, 4, 6 and 8
Change in Serum Iron From Baseline to Weeks 2, 4, 6 and 8
Measured: 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
Measured: From Baseline to the End of the study (week 8)
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8
Diastolic Blood pressure
Measured: Baseline and weeks 2, 4, 6 and 8
Body Weight at Baseline and Week 8
Measured: Baseline and week 8
Heart Rate at Baseline and Weeks 2, 4, 6 and 8
Measured: Baseline and weeks 2, 4, 6 and 8
Body Temperature at Baseline and Weeks 2, 4, 6 and 8
Measured: Baseline and weeks 2, 4, 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start3 Jul 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor (International) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Principal investigator, First Affiliated Hospital of Zhejiang UniversityZhihua Ran, Principal investigator, Renji Hospital Shanghai Jiaotong Uniersity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591406
- Sponsor's protocol ID
- VIT-IRON-2011-004
- Status last verified
- May 2021
- First submitted
- 22 Jun 2018
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03591406
- Acronym / sponsor ID
- VIT-IRON-2011-004
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Vifor (International) Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 18 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, parallel design, randomised controlled multi-centre trial in Chinese subjects
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose (FCM) | Experimental | Drug: Ferric carboxymaltoseSubjects treated with FCM given by IV injection or drip infusion |
| Iron sucrose (IS) | Active comparator | Drug: Iron sucroseSubjects treated with IS given by IV injection or drip infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseAlso: FCMDosage 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. | Drug | Ferric carboxymaltose (FCM) |
| Iron sucroseAlso: IS, Venofer™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. | Drug | Iron sucrose (IS) |
Primary outcome
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8
Time frame: From baseline at any time up to Week 8
Haemoglobin (Hb)
11 secondary outcomes
Participants Achieving an Increase in Hb of at Least 2 g/dL From Baseline to Weeks 2, 4, 6 and 8
Time frame: From Baseline to weeks 2, 4, 6 and 8
Change in Hb From Baseline to Weeks 2, 4, 6, and 8
Time frame: From Baseline to weeks 2, 4, 6 and 8
Participants With Iron Deficiency Correction Over Time by Treatment
Time frame: From Baseline to Weeks 2, 4, 6 and 8
Change in TSAT From Baseline to Weeks 2, 4, 6 and 8
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)
Time frame: From Baseline to the End of the study (week 8)
Blood Pressure at Baseline and Weeks 2, 4, 6 and 8
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Jin principal investigator
First Affiliated Hospital of Zhejiang University
Zhihua Ran principal investigator
Renji Hospital Shanghai Jiaotong Uniersity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose and Iron sucrose in people with Iron Deficiency Anemia, run by Vifor (International) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Achieving an Increase in Hb of at Least 2 g/dL at Any Time up to Week 8 (time frame: From baseline at any time up to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.