Intravenous Iron in Adults With Cystic Fibrosis

NCT03632525 | Completed Phase 4

• 1 other identifier: PID12800
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis; Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• 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)

  8 weeks

Secondary Outcomes (13)

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

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

• Change in number of antibiotic days

  16 weeks

• Change in abundance of sputum Pseudomonas

  16 weeks

• Change in sputum microbiological diversity

  16 weeks

• Change in exercise capacity (shuttle walk test)

  16 weeks

Study Arms (1)

Intravenous iron

EXPERIMENTAL

All participants will receive a single dose of intravenous ferric carboxymaltose

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltose DRUG

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).

Also known as: Ferrinject

Intravenous iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years with established diagnosis of cystic fibrosis
• Iron deficiency (transferrin saturation ≤16 % or ferritin \<15 μg/l, within last 4 months)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

John Radcliffe Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nick P Talbot, BMBCh DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 15, 2018
• Study Start: February 22, 2019
• Primary Completion: March 27, 2020
• Study Completion: October 26, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

GB (1)