IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/27/2019 |
| Start Date: | September 15, 2017 |
| End Date: | August 2019 |
Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate
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.
(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.
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.
We found this trial at
1
site
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: James Polli
Phone: 410-706-8292
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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