IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
Status:
Completed
Trial end date:
2019-04-25
Target enrollment:
Participant gender:
Summary
An approved treatment for anemia or low blood count due to chronic kidney disease is IV
(intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in
the blood. Many IV iron therapies are now available in both brand name and generic forms. One
common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit.
Recently, a generic version of Ferrlecit was approved but was felt to be possibly more toxic
than the brand product. The purpose of this research project is to see if the brand and
generic IV iron products produce the same amount of iron in the blood in healthy volunteers,
including an iron form that more toxic than other iron forms.
Phase:
Phase 4
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore