NCT02399449

IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

A generic version of Ferrlecit was approved in 2011 and is available. Shortly after the approval of the generic, a 'Reflections Paper on Non-Clinical Studies for Generic Nanoparticle Iron Medicinal Product Applications' was published by the European Medicines Agency. The authors of this paper proposed that generic iron preparations deliver increased levels of 'labile iron' to the plasma resulting in oxidative damage and toxicity. As such, studies measuring the in vivo levels of free or labile iron from generic versus brand iron-preparations were recommended. The primary outcome will be the assessment of non-inferiority of the generic colloid product against the reference colloid product with respect to non-transferrin bound iron (NTBI), after single-dose i.v. administration of brand and generic sodium ferric gluconate injections in n=48 healthy subjects.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Brand sodium ferric gluconate	brand product
DRUG	Generic sodium ferric gluconate	generic product

Timeline

• Start date: 2017-09-15
• Primary completion: 2019-03-22
• Completion: 2019-04-25
• First posted: 2015-03-26
• Last updated: 2022-09-28
• Results posted: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study