Intravenous Iron in Adults With Cystic Fibrosis

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University of Oxford

Status and phase

Completed
Phase 4

Conditions

Iron-deficiency
Cystic Fibrosis

Treatments

Drug: Ferric carboxymaltose

Study type

Interventional

Funder types

Other

Identifiers

NCT03632525
PID12800

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Intravenous iron
Experimental group
Description:
All participants will receive a single dose of intravenous ferric carboxymaltose
Treatment:
Drug: Ferric carboxymaltose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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