COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02399449
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : March 9, 2020
Information provided by (Responsible Party):
James E Polli, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: sodium ferric gluconate (brand) Drug: sodium ferric gluconate (generic) Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : April 25, 2019

Arm Intervention/treatment
Active Comparator: sodium ferric gluconate (brand)
brand-name sodium ferric gluconate
Drug: sodium ferric gluconate (brand)
brand product
Other Name: Ferrecit

Active Comparator: sodium ferric gluconate (generic)
generic sodium ferric gluconate
Drug: sodium ferric gluconate (generic)
generic product
Other Name: generic iron

Primary Outcome Measures :
  1. non-transferrin bound iron [ Time Frame: 0-36 hr ]
    area under curve

Secondary Outcome Measures :
  1. plasma total iron [ Time Frame: 0-36 hr ]
    area under curve

  2. transferrin bound iron [ Time Frame: 0-36 hr ]
    area under curve

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02399449

Layout table for location information
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Layout table for investigator information
Principal Investigator: James Polli U of Maryland
Layout table for additonal information
Responsible Party: James E Polli, Professor, University of Maryland, Baltimore Identifier: NCT02399449    
Other Study ID Numbers: HP-00060573
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by James E Polli, University of Maryland, Baltimore:
Additional relevant MeSH terms:
Layout table for MeSH terms
Ferric gluconate
Ferric Compounds