Intravenous Iron in Adults With Cystic Fibrosis

University of Oxford20 enrolled

Overview

This pilot interventional cohort study will examine the effects of intravenous iron in adults with cystic fibrosis and iron deficiency.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis Iron-deficiency

Interventions

Ferric carboxymaltoseDRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

John Radcliffe Hospital

Oxford, United Kingdom

Outcomes

Primary Outcomes

Incidence of new infective events during 4 weeks before intravenous iron, compared with 4 weeks after intravenous iron

New infective events are defined as any of: 1. New microbiological isolate on routine sputum culture (organism not cultured in 12 months prior to study) 2. Clinical infection requiring IV antibiotics (as determined by clinical team) 3. Admission to hospital for infection-related reason (as determined by clinical team) 4. Significant deterioration in lung function (\>10% fall in FEV1), not otherwise explained (as determined by clinical team)

Time frame: 8 weeks

Secondary Outcomes

Incidence of new infective events during 12 weeks before intravenous iron, compared with 12 weeks after intravenous iron

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.

Time frame: 16 weeks (plus 8 weeks of retrospective data collection from notes)

Change in number of antibiotic days

Assessed by review of clinical notes and patient self-reporting, to determine total number of days on which the patient was treated with antibiotics

Time frame: 16 weeks

Change in abundance of sputum Pseudomonas

Assessed by quantitative PCR

Time frame: 16 weeks

Change in sputum microbiological diversity

Assessed by microbiota analysis (16s rRNA gene sequencing)

Time frame: 16 weeks

Change in exercise capacity (shuttle walk test)

Standardised and validated exercise test involving exercise at progressive intensity

Data from ClinicalTrials.gov

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