Iron DeficiencyPhase 4PreferNCT01110356
Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age
A Phase 4 study testing Ferinject and Saline in people with Iron Deficiency, run by Vifor Pharma at 1 site in Austria.
Trial summary
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron Deficiency
- What is being tested?
- Ferinject and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Oct 2012
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to study specific procedures.
- Premenopausal, regularly menstruating women.
- Age ≥18 years.
- Body weight between 50 and 90 kg.
- Haemoglobin ≥115 g/L.
- Iron deficiency at screening defined as follows:
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- S-ferritin level <50 ng/mL, AND, TfS <20%, OR,
- S-ferritin level <15 ng/mL.
- Serum C-reactive protein:
- <5 mg/L if not on oral contraception, OR,
- <20 mg/L if use of oral contraception.
- Minimum total score of 5 on the Piper Fatigue Scale (PFS) (mean of items 2 to 23).
- Negative pregnancy test (serum human chorionic gonadotropin (hCG) at screening.
- Normal levels of vitamin B12 and folic acid at screening.
- Adequate contraception during the study period and for 1 month following study completion.
- Availability and willingness to complete all study visits and procedures per protocol.
Who cannot join
- Haemoglobin level <115 g/L.
- Haemoglobinopathy.
- Haemochromatose.
- Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2).
- Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV).
- Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
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- Chronic inflammatory disease (e.g., rheumatoid arthritis; inflammatory bowel disease).
- Documented history of clinically significant level of sleep apnoea defined as 5 or more episodes per hour of any type of apnoea.
- Intake of concurrent medications that could interfere with physical or mental performance (e.g., antidepressive, antihistamines, narcotic or any chemotherapeutic agents known to cause drowsiness).
- Important recent weight loss (>10% within the past month).
- Body weight <50 kg or >90 kg.
- Thyroid dysfunction, thyroid stimulating hormone >4 μU/mL.
- Intake of iron preparations 4 weeks prior to screening.
- Use of gestagens e.g., Implanon, Mirena, Depo-Provera for menstruation repression (see Section 7.7, Prohibited Therapy or Concomitant Treatment, page 35).
- Known hypersensitivity to FCM or to any other iron preparation.
- Pregnancy (positive hCG test at screening) or breast feeding.
- Participation in any other interventional trial within 4 weeks prior to screening.
- Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator's opinion.
- Subject is not using adequate contraceptive precautions during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is 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.
- Subject previously has entered this study.
- Subject will not be available for follow-up assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
- Conditions
- Iron Deficiency
- Being tested
- Ferinject, Saline
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.
SalineOther
Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ferinject | Experimental | Not described Receives: Drug: Ferinject |
| Saline | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age.
Measured: Day 56
Secondary outcomes (2)
To compare efficacy of a single IV application of FCM with that of placebo on change of iron status on Day 56 (i.e., proportion of subjects with haemoglobin (Hb) ≥12 g/dL; serum-ferritin (s-ferritin) ≥50 ng/mL; transferrin saturation (TfS) >20%).
Measured: Day 56
To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS S.A.
- Responsible party
- Sponsor
- Investigators
- Bernard Favrat, Principal investigator, Quartier UNIL-CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110356
- Sponsor's protocol ID
- IDNA 2009-01
- Acronym
- Prefer
- Status last verified
- Nov 2012
- First submitted
- 22 Apr 2010
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Favrat B, Balck K, Breymann C, Hedenus M, Keller T, Mezzacasa A, Gasche C. Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One. 2014 Apr 21;9(4):e94217. doi: 10.1371/journal.pone.0094217. eCollection 2014.
PubMed 24751822
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age
- ClinicalTrials.gov ID
- NCT01110356
- Acronym / sponsor ID
- Prefer / IDNA 2009-01
- Conditions
- Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- SGS S.A.
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 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.
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferinject | Experimental | Drug: Ferinject |
| Saline | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent prior to study specific procedures.
- Premenopausal, regularly menstruating women.
- Age ≥18 years.
- Body weight between 50 and 90 kg.
- Haemoglobin ≥115 g/L.
Key exclusion criteria (21 listed)
- Haemoglobin level <115 g/L.
- Haemoglobinopathy.
- Haemochromatose.
- Major depressive disorder based on Patient Health Questionnaire (PHQ-9) (5 items with scores ≥2; one of which corresponds to question number 1 or 2).
- Any active or unstable concurrent medical condition (e.g., cancer, renal dysfunction, liver dysfunction (aspartate aminotransferase (AST); alanine aminotransferase (ALT) >3-fold upper limit), angina (Class IV).
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 |
|---|---|---|
| FerinjectFerric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes. | Drug | Ferinject |
| SalinePlacebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes. | Other | Saline |
Primary outcome
To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age.
Time frame: Day 56
2 secondary outcomes
To compare efficacy of a single IV application of FCM with that of placebo on change of iron status on Day 56 (i.e., proportion of subjects with haemoglobin (Hb) ≥12 g/dL; serum-ferritin (s-ferritin) ≥50 ng/mL; transferrin saturation (TfS) >20%).
Time frame: Day 56
To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms.
Time frame: Day 56
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 15 Nov 2012.
- Derived from this study: PubMed 24751822Favrat B, Balck K, Breymann C, Hedenus M, Keller T, Mezzacasa A, Gasche C. Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One. 2014 Apr 21;9(4):e94217. doi: 10.1371/journal.pone.0094217. eCollection 2014.
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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.
Bernard Favrat principal investigator
Quartier UNIL-CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Saline in people with Iron Deficiency, run by Vifor Pharma at 1 site in Austria.
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 16 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 15 Nov 2012. 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 Austria. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. (time frame: Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110356, which also lists 1 linked publication.
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 15 Nov 2012.