Intravenous Iron in Adults With Cystic Fibrosis

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Ferric Compounds

Criteria

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