IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
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.
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.
Inclusion Criteria:

 -  View 1 Males or female, with age 18-65 years old, systolic blood pressure within
 90-150, and diastolic blood pressure within 60-90

 -  View 2 Healthy volunteers: Subjects in good health including being iron replete and
 not anemic, as determined by screening evaluation that is not greater than 30 days
 before the first drug study visit

 -  View 3 Willing to avoid caffeine containing products 24 hours prior to and day of
 study visits

 -  View 4 Willing to stop all OTC medications for 24 hours prior to and during study
 visits

 -  View 5 Able to provide informed consent

 Exclusion Criteria:

 -  View 1 Presence of significant medical disease (including cardiovascular, pulmonary,
 hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)

 -  View 2 Subjects who are iron deficient or with iron overload

 -  View 3 Presence of hepatic or renal disease

 -  View 4 Pregnant women, breast feeding or trying to become pregnant

 -  View 5 Excessive alcohol use (i.e. current physical, behavioral, or personal
 manifestations related to the abuse or dependency on alcohol)

 -  View 6 Routine use (i.e. daily or weekly) prescription medication except birth control
 pills

 -  View 7 Currently taking iron in any form (e.g. oral or IV)

 -  View 8 Allergic to IV iron, including sodium ferric gluconate, or any of its inactive
 components, including benzyl alcohol

 -  View 9 Undergoing therapy for solid tumor or blood malignancy

 -  View 10 Any condition in which in the opinion of the PI or medical physician would
 increase risk to the subject or interfere with the integrity of the study

 -  View 11 Donated blood within last 56 days of screening. Received IV iron or RBC
 transfusion(s) 10 days prior to screening. Plan to donate blood, or receive IV iron or
 RBC transfusion(s), during the study period.