Status:

COMPLETED

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

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Chronic Kidney Disease

Iron Deficiency

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 ...

Detailed Description

Ferric citrate is an FDA-approved oral phosphorus binder that has been shown to be effective in reducing serum phosphorus and fibroblast growth factor 23 (FGF23) concentrations and increasing iron sto...

Eligibility Criteria

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

Key Trial Info

Start Date :

September 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2019

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT02888171

Start Date

September 1 2016

End Date

March 30 2019

Last Update

March 24 2020

Active Locations (1)

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University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294