A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis.

Phase 1

• Conditions: Cystic fibrosis; MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002366-39-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Age =18 years
- Established diagnosis of cystic fibrosis
- Iron deficiency (transferrin saturation =16 % or ferritin <15 µg/l, within last four months)
- Able to provide informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Urgent (<6 weeks) need for intravenous iron
- Active infection (currently requiring IV antibiotics)
- Previous intravenous iron supplementation (within last four months)
- Current oral supplementation
- Hypersensitivity to ferric carboxymaltose
- Active non-tuberculous mycobacterial pulmonary disease (as defined by ATS-IDSA criteria)
- Liver failure
- Ferritin >300 g/l or transferrin saturation >45%
- Pregnancy or breast feeding
- Previous transplantation
- Judged by a designated member of the trial team to be unlikely to comply with safety aspects of the trial protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified