Comparing oral and intravenous iron for iron deficiency in cystic fibrosis
Compares iron by mouth with iron given into a vein, in adults with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Iron Repletion in Cystic Fibrosis
Key facts
- Where
- Ann Arbor, Charleston, Denver, Indianapolis, Kansas City, Minneapolis, New York, and Omaha, United StatesSee the 8 sites
- Phase
- Phase 4
Where in United States
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- National Jewish HealthDenver, United StatesNo longer taking part
- Indiana UniversityIndianapolis, United StatesNo longer taking part
- The University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT07903311
- Record updated
- 29 October 2026
- Original description
The researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures.Read full original descriptionShow less
A Multicenter Trial of Iron Repletion in Cystic Fibrosis: IRON-CF
The researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures.
Inclusion: A CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and at least one of the following criteria:; sweat chloride ≥ 60 milliequivalent/liter by quantitative pilocarpine iontophoresis test (QPIT); two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; abnormal nasal potential difference (NPD, change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV); Ability to provide written informed consent and to comply with the requirements of the study; --------------------------------------------------; Additional Inclusion Criteria for ID Cohort:; ID defined by at least one of the following criteria:; Both of the following: i. transferrin saturation (TSAT) < 20% OR ferritin < 30 ug/L ii. hemoglobin < 12.0 g/dL in female OR hemoglobin < 13.0 g/dL in male per World Health Organization (WHO) anemia definition b. TSAT < 15% or ferritin < 15 ug/L irrespective of hemoglobin value; --------------------------------------------------; Additional Inclusion Criteria for Borderline ID Cohort:; Borderline ID defined by both of the following criteria:; TSAT < 20% OR ferritin < 60 ug/L; not meeting ID Cohort criteria above; --------------------------------------------------.
Exclusion: Treated with IV repletion within 3 months of Screening Visit; Treated with PO repletion within 1 months of Screening Visit; Treated with red blood cell (RBC) transfusion within 3 months of Screening Visit; Prior solid organ or hematologic transplant; Pregnant, or within 3 months of a prior pregnancy at Screening Visit; Known allergy to either IV or PO iron for ID Cohort, or known allergy to PO iron for Borderline ID Cohort; Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data; Hemodialysis dependent within 6 months of Screening Visit, active use of erythropoiesis stimulating agent at time of Screening Visit, or Glomerular Filtration Rate (GFR) < 45 estimated based on creatinine (CKD-EPI 2021) at time of Screening Visit; Use of extracorporeal organ support (ECOS) of any type, including but not limited to extracorporeal membrane oxygenation (ECMO), within 6 months of Screening Visit; Presence of known cause of anemia other than ID that has required treatment within 12 months of Screening Visit.