Inflammatory Bowel DiseasePhase 3FER-IBD-CORNCT00810030
FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR
A Phase 3 study testing Ferric carboxymaltose and Iron Sucrose in people with Inflammatory Bowel Disease and Anemia, run by Vifor Pharma at 1 site in Austria.
Trial summary
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Anemia, Iron Deficiency
- 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
- 484 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2008to Apr 2010
- 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
- Signed informed consent.
- Patients ≥18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score <220, or CAI score ≤7, remission defined as CDAI score <150, or CAI score ≤4).
- Hb 7-12 g/dL (female) or 7-13 g/dL (male).
- Ferritin <100 μg/L.
- Normal levels of vitamin B12 and folic acid.
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.
Who cannot join
- Chronic alcohol abuse (alcohol consumption >20 g/day).
- Presence of portal hypertension with oesophageal varices.
- History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 4 weeks prior to screening.
- Known hypersensitivity to FERINJECT®.
- History of acquired iron overload.
- Myelodysplastic syndrome.
Show all 16Show fewer
- Pregnancy or lactation.
- Known active infection, clinically significant overt bleeding, active malignancy.
- Known chronic renal failure. Vifor Pharma - Vifor (International) Inc Clinical Study Protocol inc. Amendments 1 and 2 Protocol Number: 93842, FER-IBD-07-COR CONFIDENTIAL Final 20 of 48 10 December 2008
- Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the last 3 months prior to screening or planned surgery within the following 3 months.
- Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.
- Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- Participation in any other interventional study within 1 month prior to screening.
- Body weight <35 kg.
- Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
Read the detailed description
Anaemia in inflammatory bowel disease is mainly attributed to iron deficiency. The main cause of anaemia in IBD patients is chronic blood loss. This means that the iron storage depot in IBD patients is always low and should be replenished. Oral iron therapy is the first choice in many cases because of its safety and economy. However, in patients with gastrointestinal bleeding, the effectiveness of oral therapy is reduced. Additionally, oral iron preparations are frequently associated with gastrointestinal adverse reactions.
According to European Guidelines, the preferred route of iron supplementation in IBD is intravenous. Absolute indications for intravenous iron include severe anaemia (Hb <10 g/dL). The current study is a part of a programme investigating the efficacy and safety of FERINJECT®, a new formulation of parenteral iron (5% weight per volume iron containing ferric carboxymaltose in a solution of water for injection).
The efficacy and safety of FERINJECT® were investigated in a prospective, randomised, controlled study conducted in IBD patients. According to the results of this study, FERINJECT® provides a faster Hb response, a higher increase in iron storage and a better patient tolerance compared to oral preparations. In this study, the iron amount required was calculated according to the Ganzoni formula, where 500 mg is the amount of storage iron. To simplify the treatment and to make the treatment more effective, a new standardised dosage regimen was created. The current study is designed to assess whether this new standardised dosage regimen of i.v. FERINJECT® is as safe and effective as the currently used individually calculated dosage regimen.
The efficacy and safety of the new standardised dosage regimen of FERINJECT® will be compared with an already established, well-known treatment of IDA with iron sucrose (VENOFER®). Iron sucrose (VENOFER®) is assessed to be effective and well-tolerated in the treatment of IDA in IBD patients.
The study is a phase IIIb, multi-centre, randomised, prospective, open-label, controlled study performed at 83 study centres in 14 European countries.
The primary objective of the study is to evaluate the non-inferiority in efficacy of a standardised dosage regimen of FERINJECT® compared to individually calculated dosage regimens of VENOFER® in the correction of IDA in patients with IBD in remission. The secondary objective is to evaluate the safety and tolerability of a standardised correction dose regimen of FERINJECT®.
Approximately 420 patients will be randomised (1:1 randomisation) to receive treatment with either a standardised correction dosage regimen of FERINJECT® or individually calculated dosage regimens of VENOFER®.
Screening will start between 14 and 7 days before the first infusion is administered. Baseline assessments will be performed on Day 1 before the first infusion.
During the screening period, patients will be selected based on eligibility criteria. Patients who meet all of the inclusion criteria and none of the exclusion criteria will undergo baseline assessments at Baseline (Day 1) prior to the first dose of study medication.
Patients randomised to the FERINJECT® group will receive between 500 mg and 2000 mg of FERINJECT®, according to their Hb and body weight, in up to 3 infusions. The maximum infused weekly dose of will be 1000 mg. For patients in the VENOFER® group, the individual iron deficit will be calculated per individual using the modified formula of Ganzoni. Patients will receive one infusion of 200 mg of VENOFER® twice a week, up to 11 infusions, depending on their calculated iron deficit. Due to the relatively large doses of iron being administered, patients will be monitored carefully throughout the study for symptoms of iron overload.
All patients will return for assessment of efficacy and safety at Weeks 4, 8, and 12. The maximum study duration for a patient is 14 weeks. Patients who are not anaemic at Week 12 will be invited to continue to participate in a maintenance study (FER-IBD-07-MAIN), i.e. a study of FERINJECT® versus placebo to determine if the treatment of iron deficiency can prevent the recurrence of anaemia.
- Conditions
- Inflammatory Bowel Disease, Anemia, Iron Deficiency, Iron-Deficiency Anemia, Crohn's Disease, Ulcerative Colitis
- Being tested
- Ferric carboxymaltose, Iron Sucrose
- Keywords
- ferric carboxymaltose, iron sucrose, Iron-Deficiency Anemia, Crohn's Disease, Ulcerative Colitis, Ferritin, Transferrin
- Medical subject headings
- Inflammatory Bowel Diseases, Anemia, Iron Deficiencies, Anemia, Iron-Deficiency, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called FERINJECT®
Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight
Iron SucroseDrug
Also called VENOFER®
VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows:
- 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes.
The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes.
The individual iron deficit will be calculated using the modified formula of Ganzoni.
If the patient's body mass index is >25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height [m] x height [m].
The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg.
Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit.
| Study group | Role | What they receive |
|---|---|---|
| FERINJECT® (Ferric carboxymaltose) | Experimental | Not described Receives: Drug: Ferric carboxymaltose |
| VENOFER® (Iron Sucrose) | Active comparator | Not described Receives: Drug: Iron Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders with respect to the baseline Hb value.
Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
Measured: 12 weeks post baseline
Secondary outcomes (20)
Number of patients whose Hb increased ≥2 g/dL or who reached normal Hb levels at Week 12.
The number of patients who achieved increase of Hb ≥2 g/dL or the normal range of Hb value of Hb ≥12 (female) or ≥13 (male) g/dL) at Week 12.
Measured: 12 weeks post baseline
Change in disease activity (CDAI, CAI, C-reactive protein [CRP]).
Change in disease activity (Crohn's Disease Activity Index [CDAI], Colitis Activity Index [CAI], C-reactive protein [CRP]) at Week 12.
Measured: 12 weeks post baseline
The number of patients at Week 12: TfS: 20 to 50%.
The number of patients at Week 12: TfS: 20 to 50%.
Measured: 12 weeks post baseline
The number of non-anaemic patients at Week 12
The number of non-anaemic patients at Week 12: Hb ≥12 (female) or ≥13 (male) g/dL.
Measured: Week 12 post baseline
The number of patients with ferritin >100 µg/L at Week 12.
The number of patients with ferritin >100 µg/L at Week 12.
Measured: 12 weeks post baseline
Maximum increase in Hb, serum ferritin and TfS.
Maximum increase in Hb, serum ferritin and TfS.
Measured: 12 weeks post baseline
The number of patients at achieving Hb ≥12 (female) or ≥13 (male) g/dL and ferritin >100 µg/L at Week 12.
The number of patients at Week 12: Hb ≥12 (female) or ≥13 (male) g/dL and ferritin >100 µg/L.
Measured: 12 weeks post baseline
The number of patients withdrawal from study due to protocol procedure.
The number of patients withdrawal from study due to protocol procedure.
Measured: 12 weeks post baseline
The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease.
The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease.
Measured: 12 weeks post baseline
The number of patients with Hb baseline value ≤10 g/dL who achieved Hb increase ≥2 g/dL and the number of patients with Hb baseline value >10 g/dL who achieved Hb increase ≥2 g/dL.
The number of patients with Hb baseline value ≤10 g/dL who achieved Hb increase ≥2 g/dL and the number of patients with Hb baseline value >10 g/dL who achieved Hb increase ≥2 g/dL.
Measured: 12 weeks post baseline
Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ.
Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ.
Measured: 12 weeks post baseline
The number of patients out of work due to anaemia or IBD.
The number of patients out of work due to anaemia or IBD.
Measured: 12 weeks post baseline
Days out of hospital.
Days out of hospital.
Measured: 12 weeks post baseline
Hospitalisation rate
Hospitalisation rate (hospitalisation due to anaemia and/or IBD).
Measured: 12 weeks post baseline
Adverse events: type, nature, incidence and outcome.
Adverse events: type, nature, incidence and outcome.
Measured: 12 weeks post baseline
Vital signs (blood pressure, pulse rate and bw).
Vital signs (blood pressure, pulse rate and bw).
Measured: 12 weeks post baseline
Electrocardiogram.
Electrocardiogram.
Measured: 12 weeks post baseline
Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis).
Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis).
Measured: 12 weeks post baseline
Physical examination.
Physical examination.
Measured: 12 weeks post baseline
The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
Measured: 12 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, ClinStar, LLC
- Responsible party
- Sponsor
- Investigators
- Christoph Gasche, Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810030
- Sponsor's protocol ID
- FER-IBD-07-COR
- Acronym
- FER-IBD-COR
- Status last verified
- Dec 2012
- First submitted
- 16 Dec 2008
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00810030
- Acronym / sponsor ID
- FER-IBD-COR / FER-IBD-07-COR
- Conditions
- Inflammatory Bowel Disease, Anemia, Iron Deficiency, Iron-Deficiency Anemia, Crohn's Disease, Ulcerative Colitis
- Keywords
- ferric carboxymaltose, iron sucrose, Iron-Deficiency Anemia, Crohn's Disease, Ulcerative Colitis, Ferritin, Transferrin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel, ClinStar, LLC
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Dec 2008 (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.
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
Detailed description
Anaemia in inflammatory bowel disease is mainly attributed to iron deficiency. The main cause of anaemia in IBD patients is chronic blood loss. This means that the iron storage depot in IBD patients is always low and should be replenished. Oral iron therapy is the first choice in many cases because of its safety and economy. However, in patients with gastrointestinal bleeding, the effectiveness of oral therapy is reduced. Additionally, oral iron preparations are frequently associated with gastrointestinal adverse reactions.
According to European Guidelines, the preferred route of iron supplementation in IBD is intravenous. Absolute indications for intravenous iron include severe anaemia (Hb <10 g/dL). The current study is a part of a programme investigating the efficacy and safety of FERINJECT®, a new formulation of parenteral iron (5% weight per volume iron containing ferric carboxymaltose in a solution of water for injection).
The efficacy and safety of FERINJECT® were investigated in a prospective, randomised, controlled study conducted in IBD patients. According to the results of this study, FERINJECT® provides a faster Hb response, a higher increase in iron storage and a better patient tolerance compared to oral preparations. In this study, the iron amount required was calculated according to the Ganzoni formula, where 500 mg is the amount of storage iron. To simplify the treatment and to make the treatment more effective, a new standardised dosage regimen was created. The current study is designed to assess whether this new standardised dosage regimen of i.v. FERINJECT® is as safe and effective as the currently used individually calculated dosage regimen.
The efficacy and safety of the new standardised dosage regimen of FERINJECT® will be compared with an already established, well-known treatment of IDA with iron sucrose (VENOFER®). Iron sucrose (VENOFER®) is assessed to be effective and well-tolerated in the treatment of IDA in IBD patients.
The study is a phase IIIb, multi-centre, randomised, prospective, open-label, controlled study performed at 83 study centres in 14 European countries.
The primary objective of the study is to evaluate the non-inferiority in efficacy of a standardised dosage regimen of FERINJECT® compared to individually calculated dosage regimens of VENOFER® in the correction of IDA in patients with IBD in remission. The secondary objective is to evaluate the safety and tolerability of a standardised correction dose regimen of FERINJECT®.
Approximately 420 patients will be randomised (1:1 randomisation) to receive treatment with either a standardised correction dosage regimen of FERINJECT® or individually calculated dosage regimens of VENOFER®.
Screening will start between 14 and 7 days before the first infusion is administered. Baseline assessments will be performed on Day 1 before the first infusion.
During the screening period, patients will be selected based on eligibility criteria. Patients who meet all of the inclusion criteria and none of the exclusion criteria will undergo baseline assessments at Baseline (Day 1) prior to the first dose of study medication.
Patients randomised to the FERINJECT® group will receive between 500 mg and 2000 mg of FERINJECT®, according to their Hb and body weight, in up to 3 infusions. The maximum infused weekly dose of will be 1000 mg. For patients in the VENOFER® group, the individual iron deficit will be calculated per individual using the modified formula of Ganzoni. Patients will receive one infusion of 200 mg of VENOFER® twice a week, up to 11 infusions, depending on their calculated iron deficit. Due to the relatively large doses of iron being administered, patients will be monitored carefully throughout the study for symptoms of iron overload.
All patients will return for assessment of efficacy and safety at Weeks 4, 8, and 12. The maximum study duration for a patient is 14 weeks. Patients who are not anaemic at Week 12 will be invited to continue to participate in a maintenance study (FER-IBD-07-MAIN), i.e. a study of FERINJECT® versus placebo to determine if the treatment of iron deficiency can prevent the recurrence of anaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FERINJECT® (Ferric carboxymaltose) | Experimental | Drug: Ferric carboxymaltose |
| VENOFER® (Iron Sucrose) | Active comparator | Drug: Iron Sucrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Patients ≥18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score <220, or CAI score ≤7, remission defined as CDAI score <150, or CAI score ≤4).
- Hb 7-12 g/dL (female) or 7-13 g/dL (male).
- Ferritin <100 μg/L.
- Normal levels of vitamin B12 and folic acid.
Key exclusion criteria (16 listed)
- Chronic alcohol abuse (alcohol consumption >20 g/day).
- Presence of portal hypertension with oesophageal varices.
- History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 4 weeks prior to screening.
- Known hypersensitivity to FERINJECT®.
- History of acquired iron overload.
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: FERINJECT®Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight | Drug | FERINJECT® (Ferric carboxymaltose) |
| Iron SucroseAlso: VENOFER®VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows: • 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes. The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes. The individual iron deficit will be calculated using the modified formula of Ganzoni. If the patient's body mass index is >25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height [m] x height [m]. The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg. Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit. | Drug | VENOFER® (Iron Sucrose) |
Primary outcome
Number of responders with respect to the baseline Hb value.
Time frame: 12 weeks post baseline
Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
20 secondary outcomes
Number of patients whose Hb increased ≥2 g/dL or who reached normal Hb levels at Week 12.
Time frame: 12 weeks post baseline
Change in disease activity (CDAI, CAI, C-reactive protein [CRP]).
Time frame: 12 weeks post baseline
The number of patients at Week 12: TfS: 20 to 50%.
Time frame: 12 weeks post baseline
The number of non-anaemic patients at Week 12
Time frame: Week 12 post baseline
The number of patients with ferritin >100 µg/L at Week 12.
Time frame: 12 weeks post baseline
Maximum increase in Hb, serum ferritin and TfS.
Time frame: 12 weeks post baseline
The number of patients at achieving Hb ≥12 (female) or ≥13 (male) g/dL and ferritin >100 µg/L at Week 12.
Time frame: 12 weeks post baseline
The number of patients withdrawal from study due to protocol procedure.
Time frame: 12 weeks post baseline
The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease.
Time frame: 12 weeks post baseline
The number of patients with Hb baseline value ≤10 g/dL who achieved Hb increase ≥2 g/dL and the number of patients with Hb baseline value >10 g/dL who achieved Hb increase ≥2 g/dL.
Time frame: 12 weeks post baseline
Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ.
Time frame: 12 weeks post baseline
The number of patients out of work due to anaemia or IBD.
Time frame: 12 weeks post baseline
Days out of hospital.
Time frame: 12 weeks post baseline
Hospitalisation rate
Time frame: 12 weeks post baseline
Adverse events: type, nature, incidence and outcome.
Time frame: 12 weeks post baseline
Vital signs (blood pressure, pulse rate and bw).
Time frame: 12 weeks post baseline
Electrocardiogram.
Time frame: 12 weeks post baseline
Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis).
Time frame: 12 weeks post baseline
Physical examination.
Time frame: 12 weeks post baseline
The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.
Time frame: 12 weeks post 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 21 Dec 2012.
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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.
Christoph Gasche, Professor principal investigator
Medical University of Vienna
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 Inflammatory Bowel Disease and Anemia, 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 6 inclusion and 16 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 21 Dec 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. 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?
Number of responders with respect to the baseline Hb value. (time frame: 12 weeks 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 21 Dec 2012.