IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
Condition: Anemia
Intervention: Brand sodium ferric gluconate; Generic sodium ferric gluconate
Intervention description: brand product; generic product
Intervention MeSH terms: Ferric gluconate; Ferric Compounds
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: iron; pharmacokinetics

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.
    

Eligibility criteria:

        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.