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IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02399449
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
James E Polli, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE March 26, 2015
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
non-transferrin bound iron [ Time Frame: 0-36 hr ]
area under curve
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02399449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
  • plasma total iron [ Time Frame: 0-36 hr ]
    area under curve
  • transferrin bound iron [ Time Frame: 0-36 hr ]
    area under curve
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
Official Title  ICMJE Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate
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 i.v. administration of brand and generic sodium ferric gluconate injections in n=48 healthy subjects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Anemia
Intervention  ICMJE
  • Drug: sodium ferric gluconate (brand)
    brand product
    Other Name: Ferrecit
  • Drug: sodium ferric gluconate (generic)
    generic product
    Other Name: generic iron
Study Arms  ICMJE
  • Active Comparator: sodium ferric gluconate (brand)
    brand-name sodium ferric gluconate
    Intervention: Drug: sodium ferric gluconate (brand)
  • Active Comparator: sodium ferric gluconate (generic)
    generic sodium ferric gluconate
    Intervention: Drug: sodium ferric gluconate (generic)
Publications * Baribeault D. Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers. Curr Med Res Opin. 2011 Aug;27(8):1653-7. doi: 10.1185/03007995.2011.597738. Epub 2011 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
110
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2015)
44
Actual Study Completion Date  ICMJE April 25, 2019
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02399449
Other Study ID Numbers  ICMJE HP-00060573
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James E Polli, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Polli U of Maryland
PRS Account University of Maryland, Baltimore
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP