Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency

Trial end date:
Target enrollment:
Participant gender:
The main objective of the study is to compare the impact of oral ferric citrate compared to standard of care oral ferrous sulfate on serum iron, percent transferrin saturation, ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic kidney disease (CKD) and absolute iron deficiency.
Accepts Healthy Volunteers?
Lead Sponsor:
University of Alabama at Birmingham
Citric Acid
Ferric Compounds
Inclusion Criteria:

- Age 18 years or greater

- Moderate to severe CKD not requiring dialysis (eGFR 15 - 45 ml/min/1.73 m2 by CKD-EPI)

- Absolute iron deficiency (serum ferritin <300ng/ml and Transferrin Saturation < 30%)

Exclusion Criteria:

- Hemoglobin concentrations > 13 g/dL

- Known disorder of iron homeostasis (e.g., hemochromatosis)

- Known gastrointestinal disorder (irritable bowel disease, inflammatory bowel disease)

- Known liver disease (ALT/AST or bilirubin > 3x normal)

- Serum phosphorus concentrations < 3.0 mg/dL

- Any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)

- Symptomatic gastrointestinal bleeding within 12 weeks prior to the screening visit.

- Subjects receiving any form of renal replacement therapy including hemodialysis,
peritoneal dialysis, or renal transplant.

- Pregnancy or lactation in female participants

- Severe anemia defined as a hemoglobin < 8.0 g/dL for males or a hemoglobin <7.0 g/dL
for females.

- Receipt of erythropoiesis stimulating agents within 4 weeks of screening.

- Receipt of intravenous iron therapy within 8 weeks of screening.

- Blood transfusion within 4 weeks of screening

- Known allergies or severe adverse reactions to previous oral iron therapy

- Current use of oral phosphorus binders.

- Current use of an active vitamin D analog