Clinical Research Directory

Inclusion Criteria for All Study Participants: 1. A CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and at least one of the following criteria: 1. sweat chloride ≥ 60 milliequivalent/liter by quantitative pilocarpine iontophoresis test (QPIT) 2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene 3. abnormal nasal potential difference (NPD, change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV) 2. Ability to provide written informed consent and to comply with the requirements of the study \-------------------------------------------------- Additional Inclusion Criteria for ID Cohort: 3. ID defined by at least one of the following criteria: a. 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: 4. Borderline ID defined by both of the following criteria: 1. TSAT \< 20% OR ferritin \< 60 ug/L 2. not meeting ID Cohort criteria above \-------------------------------------------------- Exclusion Criteria for All Study Participants: 1. Treated with IV repletion within 3 months of Screening Visit 2. Treated with PO repletion within 1 months of Screening Visit 3. Treated with red blood cell (RBC) transfusion within 3 months of Screening Visit 4. Known allergy to either IV or PO iron for ID Cohort, or known allergy to PO iron for Borderline ID Cohort 5. Prior solid organ or hematologic transplant 6. 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 7. Use of extracorporeal organ support (ECOS) of any type, including but not limited to extracorporeal membrane oxygenation (ECMO), within 6 months of Screening Visit 8. Pregnant, or within 3 months of a prior pregnancy at Screening Visit 9. Presence of known cause of anemia other than ID that has required treatment within 12 months of Screening Visit 10. 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