Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02399449
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2015-03-02
Brief Title:
IV Iron Safety Evaluation of Iron Species in Healthy Subjects
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 iv administration of brand and generic sodium ferric gluconate injections in n48 healthy subjects
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 iv administration of brand and generic sodium ferric gluconate injections in n48 healthy subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None