NCT03632525

Intravenous Iron in Adults With Cystic Fibrosis

A Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cystic Fibrosis
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	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).

Timeline

• Start date: 2019-02-22
• Primary completion: 2020-03-27
• Completion: 2021-10-26
• First posted: 2018-08-15
• Last updated: 2022-09-07

Locations

1 site across 1 country: United Kingdom