Iron-Deficiency AnemiaPhase 3FID-CHEMONCT01101399
Ferric Carboxymaltose in Subjects With Functional Iron Deficiency Undergoing Chemotherapy
A Phase 3 study testing Ferric carboxymaltose in people with Iron-Deficiency Anemia, run by Vifor Pharma at 2 sites in 2 countries.
Trial summary
Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, conditions which reduce significantly the quality of life and increase morbidity and mortality. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2010to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subjects (male or female) aged ≥18, suffering from indolent non-Hodgkin's lymphoma, multiple myeloma or chronic lymphocytic leukaemia on any chemotherapy excluding anthracycline containing.
- Life expectancy at least 6 months.
- Received at least 12 weeks (or 3 cycles) of treatment in the current course of chemotherapy before start of iron therapy.
- 8.5 g/dL Hb 10.5 g/dL at time of randomisation.
- Iron-restricted erythropoiesis as defined:
- Stainable iron in bone marrow combined with transferrin saturation (TSAT) ≤20% OR
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- where the evaluation of stainable iron in bone marrow is not possible or available:
- ferritin >30 ng/mL (women) or >40 ng/mL (men) and
- TSAT ≤20%
- Signed informed consent (before any study procedure).
- Females of child-bearing potential must have a negative urine pregnancy test.
Who cannot join
- Any anaemia treatment within 4 weeks before inclusion (including red blood cell transfusion, ESA treatment and any oral/parenteral iron supplementation).
- Subjects weighing <35 kg.
- Subjects with increase in Hb during the chemotherapy (>1 g/dL rise between initiation of CT and screening laboratory value).
- Folate deficiency (serum folate <4.5 nmol/L) and/or vitamin B12 deficiency (serum cobalamin <145 pmol/L).
- Ongoing haemolysis defined as serum haptoglobin <0.2 g/L.
- Recent significant bleeding/surgery.
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- Monotherapy with immunotherapy agents.
- Known chronic renal failure, creatinine >125 μmol/L.
- Anthracycline containing chemotherapy regimens.
- Clinically relevant active inflammatory disease other than the malignant disease (according to the judgement of the Investigator).
- Clinically relevant ongoing infectious disease including known human immunodeficiency virus.
- Serum-ferritin >800 ng/mL.
- Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia.
- Significant cardiovascular disease prior to study inclusion including myocardial infarction within 12 months prior to study inclusion, congestive heart failure New York Heart Association (NYHA) Grade III or IV, or poorly controlled hypertension according to the judgment of the Investigator.
- Elevation of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 3 times above the normal range or known acute hepatic disorder.
- 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).
- Females who are evidently pregnant (e.g., positive HCG test) or are breast feeding.
- Subject is not using adequate contraceptive precautions. Adequate contraceptive precautions 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 amenorrhea for at least 12 months.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for follow-up assessment.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
Department of Medicine, St Görans Hospital (Capio St Görans Sjukhus)
Stockholm, SE-112 81
About this study
Official title: Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy
Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in subjects suffering from lymphoid malignancies.
Read the detailed description
Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of FCM in the treatment of anaemia in LPD subjects with functional iron deficiency (FID), undergoing chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion to receive intravenous (IV) infusions of FCM or no FCM infusions (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). After randomisation, the visits are scheduled weekly until Week 8.
- Conditions
- Iron-Deficiency Anemia
- Being tested
- Ferric carboxymaltose
- Keywords
- Anemia, Lymphoproliferative Disorders, Chemotherapy, ferric carboxymaltose, iron
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2).
Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Subjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2). Receives: Drug: Ferric carboxymaltose |
| Local standard of care. | No intervention | Subjects will be treated according to the local institutional practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemoglobin from baseline to Week 4
Measured: Weeks 4 post baseline
Secondary outcomes (3)
The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment.
Measured: 12 weeks post baseline
Change in haemoglobin from baseline to Week 6
Measured: 6 weeks after baseline
Change in haemoglobin from baseline to Week 8
Measured: 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torbjörn Karlsson, MD, PhD, Principal investigator, Capio St Görans Sjukhus, StockholmMorgan McNamara, Study director, Vifor Pharma, CH-8152 Glattbrugg, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101399
- Sponsor's protocol ID
- FER-FID-CHEMO
- Acronym
- FID-CHEMO
- Status last verified
- Dec 2013
- First submitted
- 30 Mar 2010
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Lymphoid Malignancies & Functional Iron Deficiency Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01101399
- Acronym / sponsor ID
- FID-CHEMO / FER-FID-CHEMO
- Conditions
- Iron-Deficiency Anemia
- Keywords
- Anemia, Lymphoproliferative Disorders, Chemotherapy, ferric carboxymaltose, iron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anaemia and functional iron deficiency are common conditions in patients with lymphoid malignancies, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with lymphoid malignancies: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM in the correction of haemoglobin levels in anaemic subjects with lymphoid malignancies, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in subjects suffering from lymphoid malignancies.
Detailed description
Multicentre, randomised, controlled, 2-arm open-label prospective pilot study to evaluate efficacy and safety of FCM in the treatment of anaemia in LPD subjects with functional iron deficiency (FID), undergoing chemotherapy. The subjects will be screened for eligibility within 4 weeks prior to inclusion to receive intravenous (IV) infusions of FCM or no FCM infusions (the subjects may be treated according to the local institutional practice if requiring symptomatic management of anaemia). After randomisation, the visits are scheduled weekly until Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Drug: Ferric carboxymaltoseSubjects will receive a total dose of 1,000 mg iron as FCM on the day of the next scheduled chemotherapy cycle after randomisation or continuous chemotherapy. In subjects with weight ≤66 kg, the first dose iron will be 500 mg; the second dose (500 mg) will be administered on the visit 4 (week 2). |
| Local standard of care. | No intervention | –Subjects will be treated according to the local institutional practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects (male or female) aged ≥18, suffering from indolent non-Hodgkin's lymphoma, multiple myeloma or chronic lymphocytic leukaemia on any chemotherapy excluding anthracycline containing.
- Life expectancy at least 6 months.
- Received at least 12 weeks (or 3 cycles) of treatment in the current course of chemotherapy before start of iron therapy.
- 8.5 g/dL Hb 10.5 g/dL at time of randomisation.
- Iron-restricted erythropoiesis as defined:
Key exclusion criteria (21 listed)
- Any anaemia treatment within 4 weeks before inclusion (including red blood cell transfusion, ESA treatment and any oral/parenteral iron supplementation).
- Subjects weighing <35 kg.
- Subjects with increase in Hb during the chemotherapy (>1 g/dL rise between initiation of CT and screening laboratory value).
- Folate deficiency (serum folate <4.5 nmol/L) and/or vitamin B12 deficiency (serum cobalamin <145 pmol/L).
- Ongoing haemolysis defined as serum haptoglobin <0.2 g/L.
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: FerinjectSubjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline. Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2). Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy. | Drug | Ferric carboxymaltose |
Primary outcome
Change in haemoglobin from baseline to Week 4
Time frame: Weeks 4 post baseline
3 secondary outcomes
The percentage of subjects with blood haemoglobin increase of at least 1 g/dL in the absence of any red cell transfusion or ESA treatment.
Time frame: 12 weeks post baseline
Change in haemoglobin from baseline to Week 6
Time frame: 6 weeks after baseline
Change in haemoglobin from baseline to Week 8
Time frame: 8 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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.
Torbjörn Karlsson, MD, PhD principal investigator
Capio St Görans Sjukhus, Stockholm
Morgan McNamara study director
Vifor Pharma, CH-8152 Glattbrugg, Switzerland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose in people with Iron-Deficiency Anemia, run by Vifor Pharma at 2 sites in 2 countries.
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 11 inclusion and 21 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in haemoglobin from baseline to Week 4 (time frame: Weeks 4 post baseline). 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 18 Dec 2013.