- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632525
Intravenous Iron in Adults With Cystic Fibrosis
September 6, 2022 updated by: University of Oxford
A Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic Fibrosis
This pilot interventional cohort study will examine the effects of intravenous iron in adults with cystic fibrosis and iron deficiency.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Iron deficiency is common in adults with cystic fibrosis, and is associated with adverse outcomes.
Oral iron supplementation is poorly tolerated and may be ineffective.
In some centres, intravenous iron is used to correct iron deficiency, but concerns have been raised about the safety of this treatment in the setting of chronic airways infection.
The investigators are therefore planning a pilot interventional cohort study examining the effects of intravenous iron in a group of adults with cystic fibrosis.
Patients will be recruited in Oxford and studied prospectively over 16 weeks, with iron given at week 4.
The primary focus of this single-centre pilot/feasibility study is safety, specifically in relation to infection.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oxford, United Kingdom
- John Radcliffe Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years with established diagnosis of cystic fibrosis
- Iron deficiency (transferrin saturation ≤16 % or ferritin <15 μg/l, within last 4 months)
Exclusion Criteria:
- Urgent (<6 weeks) need for iron supplementation
- Active infection (currently requiring IV antibiotics)
- Previous intravenous iron supplementation (within last 4 months)
- Current oral iron supplementation
- Hypersensitivity to ferric carboxymaltose
- Active non-tuberculous mycobacterial pulmonary disease (as defined by ATS-IDSA criteria)
- Liver failure
- Ferritin >300 μg/l or transferrin saturation >45%
- Pregnancy or breast feeding
- Previous transplantation
- Judged by member of trial team to be unlikely to comply with safety aspects of trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intravenous iron
All participants will receive a single dose of intravenous ferric carboxymaltose
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Single dose of 20 mg/kg ferric carboxymaltose (maximum 1000 mg for patients with haemoglobin <14 g/dL or 500 mg for patients with haemoglobin ≥14 g/dL).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of new infective events during 4 weeks before intravenous iron, compared with 4 weeks after intravenous iron
Time Frame: 8 weeks
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New infective events are defined as any of:
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of new infective events during 12 weeks before intravenous iron, compared with 12 weeks after intravenous iron
Time Frame: 16 weeks (plus 8 weeks of retrospective data collection from notes)
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Infective events are defined as per primary outcome.
Data relating to the 8 weeks prior to the 16-week prospective study period will be obtained from the medical records.
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16 weeks (plus 8 weeks of retrospective data collection from notes)
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Change in number of antibiotic days
Time Frame: 16 weeks
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Assessed by review of clinical notes and patient self-reporting, to determine total number of days on which the patient was treated with antibiotics
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16 weeks
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Change in abundance of sputum Pseudomonas
Time Frame: 16 weeks
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Assessed by quantitative PCR
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16 weeks
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Change in sputum microbiological diversity
Time Frame: 16 weeks
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Assessed by microbiota analysis (16s rRNA gene sequencing)
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16 weeks
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Change in exercise capacity (shuttle walk test)
Time Frame: 16 weeks
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Standardised and validated exercise test involving exercise at progressive intensity
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16 weeks
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Change in lung function (FEV1)
Time Frame: 16 weeks
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Assessed by spirometry
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16 weeks
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Change in arterial oxygen saturation
Time Frame: 16 weeks
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Assessed by non-invasive pulse oximetry
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16 weeks
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Change in body mass index
Time Frame: 16 weeks
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Calculated by standard formula: BMI=weight/(height squared)
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16 weeks
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Change in quality of life (CFQ-R questionnaire)
Time Frame: 16 weeks
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The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a 48-item questionnaire that provides scores in twelve quality of life domains (physical functioning, vitality, emotional state, social limitations, role limitations, embarrassment, body image, eating disturbance, treatment constraints) and three symptom domains (respiratory, digestive, weight).
Scores ranging from 0 to 100 are calculated for each quality of life domain, using a published method, where a higher score indicates a more favourable health status.
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16 weeks
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Change in quality of life (SF-36 questionnaire)
Time Frame: 16 weeks
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The 36-item short form questionnaire (SF-36) provides scores in eight major domains of health (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions).
Each is scored on a scale from 0-100, where a higher value represents a more favourable health status.
The domains may be combined to provide two summary scores, namely the 'physical component summary' and the 'mental component summary', each of which is also scored from 0-100.
In calculating the respective summary scores, subscales related to physical or psychological health (as appropriate) are positively weighted, according to a published method.
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16 weeks
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Change in pulmonary artery pressure, assessed by echocardiography (exploratory outcome)
Time Frame: 16 weeks
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Assessed via changes in tricuspid regurgitant jet velocity
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16 weeks
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Percentage of eligible patients entering and completing the study
Time Frame: 16 weeks
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Calculated based on number of eligible patients that enter and/or complete the study.
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16 weeks
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Percentage of patient in whom each outcome is successfully measured
Time Frame: 16 weeks
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Calculated based on number of participating patients in whom each outcome is measured.
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nick P Talbot, BMBCh DPhil, University of Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 22, 2019
Primary Completion (ACTUAL)
March 27, 2020
Study Completion (ACTUAL)
October 26, 2021
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (ACTUAL)
August 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 6, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hematologic Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Anemia, Hypochromic
- Anemia
- Iron Metabolism Disorders
- Pancreatic Diseases
- Fibrosis
- Anemia, Iron-Deficiency
- Cystic Fibrosis
Other Study ID Numbers
- PID12800
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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