Anemia, Iron DeficiencyFRESHNCT03247816

Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

An observational study of Anemia, Iron Deficiency and Inflammatory Bowel Diseases, run by Shield Therapeutics at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Anemia, Iron Deficiency, Inflammatory Bowel Diseases
How many people: 59 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Aug 2017to 1 Oct 2018
Phase: Observational
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Real World subjects with IBD (Crohn's disease or ulcerative colitis) who are also diagnosed with mild-moderate IDA.

Who may be able to join

Male and female patients aged ≥ 18 years at the time of initiation .
Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females
Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% .
Patient receiving Feraccru® since the time of UK launch in June 2016.

Who cannot join

Patient receiving Feraccru® as part of an interventional clinical trial.
Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
Patient with an IBD flare, as determined by the clinician.
Patient with medical records that are not available for review.
Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Southampton General Hospital
Southampton

Other trials in United Kingdom

About this study

Official title: Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A Real World Study to Describe the Outcomes Associated With the Use of Ferric Maltol (Feraccru) for the Management of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease in the UK.

Read the detailed description

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Conditions: Anemia, Iron Deficiency, Inflammatory Bowel Diseases
Medical subject headings: Anemia, Iron-Deficiency, Inflammatory Bowel Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.
Measured: 12 weeks (permitting 10-16 weeks)

Secondary outcomes (19)

Change in Hb Levels at Week 4
Change in Haemoglobin levels from baseline to Week 4
Measured: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Hb Levels at 12 Weeks
Change in Haemoglobin levels from baseline to Week 12
Measured: Baseline to Week 12 (permitting 10-16 weeks)
Time to Normalisation of Hb Levels
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.
Measured: Baseline to 12 weeks (permitting 10-16 weeks)
Change in Serum Ferritin Levels at Week 4
Change in serum ferritin levels from baseline to week 4
Measured: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Serum Ferritin Levels at Week 12
Change in serum ferritin levels from baseline to week 12
Measured: Baseline to Week 12 (permitting 10-16 weeks)
Percentage of Patients With Normalised Ferritin Levels at 12 Weeks
Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
Measured: Baseline to Week 12 (permitting 10-16 weeks)
Time to Correction of Serum Ferritin Levels
Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
Measured: Baseline to Week 12 (permitting 10 to 16 weeks)
Change in Transferrin Saturation at Week 4
Change in transferrin saturation (TSAT) at Week 4
Measured: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Transferrin Saturation at Week 12
Change in transferrin saturation (TSAT) at Week 12
Measured: Baseline to Week 12
Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®
Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
Measured: Baseline to Week 12
Time to Correction of Transferrin Saturation
Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
Measured: Baseline to Week 12
Time From Diagnosis of IBD to Initiation of Feraccru
Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.
Measured: Baseline
Time From Diagnosis of IDA to Initiation of Feraccru®
Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®
Measured: Baseline
Prior IV Treatment History
Prior intravenous iron treatment history
Measured: Baseline
Reason for Initiating Feraccru®
Reason(s) for initiation of Feraccru®
Measured: Baseline
Percentage of Patients Who Discontinue Feraccru®
Percentage of patients who discontinue Feraccru® during the 12 weeks period
Measured: Baseline to week 12
Reason for Discontinuing Feraccru®
Reasons for stopping will be collected as predefined common options and a free text field.
Measured: Baseline to week 12
Adverse Events That Are Related to and Caused by Feraccru®
Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®
Measured: For the duration of study, average of 12 weeks.
Reason for Discontinuing Each Prior Oral Ferrous Product
Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 20171 Oct 2018

First posted14 Aug 2017
Study start14 Aug 2017
Primary completion1 Mar 2018
Study completion1 Oct 2018

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 Anemia, 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03247816
Sponsor's protocol ID: ST10-01-401
Acronym: FRESH
Status last verified: Sep 2020
First submitted: 12 Mar 2017
Last updated: 23 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia, Iron Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A Real World Study to Describe the Outcomes Associated With the Use of Ferric Maltol (Feraccru) for the Management of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease in the UK.
ClinicalTrials.gov ID: NCT03247816
Acronym / sponsor ID: FRESH / ST10-01-401
Conditions: Anemia, Iron Deficiency, Inflammatory Bowel Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Shield TherapeuticsIndustry (pharma, biotech, devices)
Study start: 14 Aug 2017 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 1 Oct 2018 (actual)
First posted: 14 Aug 2017 (actual)
Results: Posted 25 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Real World subjects with IBD (Crohn's disease or ulcerative colitis) who are also diagnosed with mild-moderate IDA.

Key inclusion criteria (4 listed)

Male and female patients aged ≥ 18 years at the time of initiation .
Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females
Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% .
Patient receiving Feraccru® since the time of UK launch in June 2016.

Key exclusion criteria (5 listed)

Patient receiving Feraccru® as part of an interventional clinical trial.
Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
Patient with an IBD flare, as determined by the clinician.
Patient with medical records that are not available for review.
Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
Time frame: 12 weeks (permitting 10-16 weeks)
Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

19 secondary outcomes

Change in Hb Levels at Week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Hb Levels at 12 Weeks
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Time to Normalisation of Hb Levels
Time frame: Baseline to 12 weeks (permitting 10-16 weeks)
Change in Serum Ferritin Levels at Week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Serum Ferritin Levels at Week 12
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Percentage of Patients With Normalised Ferritin Levels at 12 Weeks
Time frame: Baseline to Week 12 (permitting 10-16 weeks)
Time to Correction of Serum Ferritin Levels
Time frame: Baseline to Week 12 (permitting 10 to 16 weeks)
Change in Transferrin Saturation at Week 4
Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Transferrin Saturation at Week 12
Time frame: Baseline to Week 12
Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®
Time frame: Baseline to Week 12
Time to Correction of Transferrin Saturation
Time frame: Baseline to Week 12
Time From Diagnosis of IBD to Initiation of Feraccru
Time frame: Baseline
Time From Diagnosis of IDA to Initiation of Feraccru®
Time frame: Baseline
Prior IV Treatment History
Time frame: Baseline
Reason for Initiating Feraccru®
Time frame: Baseline
Percentage of Patients Who Discontinue Feraccru®
Time frame: Baseline to week 12
Reason for Discontinuing Feraccru®
Time frame: Baseline to week 12
Adverse Events That Are Related to and Caused by Feraccru®
Time frame: For the duration of study, average of 12 weeks.
Reason for Discontinuing Each Prior Oral Ferrous Product
Time frame: Baseline

Results and safety

Results posted to the registry on 25 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Number of Eligible Subjects	59	30

Primary outcome: The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.

Time frame: 12 weeks (permitting 10-16 weeks). Count of participants. Unit: Participants

Measure	Normalised Hb at 12 Weeks n = 30	Not Normalised Hb at 12 Weeks n = 30
Value	19	11

Population analysed: Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to approximately 12 weeks (permitting 10-16 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number of Eligible Subjects	1 of 59 (1.7%)	9 of 59 (15.3%)	0 of 59

Limitations and caveats (from the sponsor): Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Anemia, Iron Deficiency

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Iron Deficiency and Inflammatory Bowel Diseases, run by Shield Therapeutics at 1 site in United Kingdom.

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 4 inclusion and 5 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 23 Oct 2020. 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 United Kingdom. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 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?

The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. (time frame: 12 weeks (permitting 10-16 weeks)). 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 NCT03247816.

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 23 Oct 2020; AzTrials last refreshed its copy on 30 Oct 2026.