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

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 hemoglobin levels in individuals with moderate to severe chronic kidney disease (CKD) and absolute iron deficiency.

Timeline

Start

2016-09

Primary completion

2019-02-12

Completion

2019-03-30

Outcome

Met primary endpoint

paper There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15; P=0.02) PMID 32694162 ↗

paper and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64; P=0.009) PMID 32694162 ↗

Publications

• Womack R, Berru F, Panwar B, Gutierrez OM. Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1251-1258. doi: 10.2215/CJN.15291219. Epub 2020 Jul 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferric Citrate	Unknown	2 g	Oral
Comparator	Ferrous Sulfate	Diagnostic / imaging agent	325 mg	Oral

Indications