IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

NCT02399449 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HP-00060573
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

iron; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Non-transferrin Bound Iron

  area under curve of non-transferrin bound iron. Non-transferrin bound iron is the difference between plasma total iron and transferrin bound iron, both of which were directly quantified. Units are concentration x time (i.e. ppb x hr).

  0-36 hr

Secondary Outcomes (2)

• Plasma Total Iron

  0-36 hr

• Transferrin Bound Iron

  0-36 hr

Study Arms (2)

Brand sodium ferric gluconate then Generic sodium ferric gluconate

EXPERIMENTAL

Crossover trial. Each arm will receive Brand sodium ferric gluconate (single dose of 125mg) then Generic sodium ferric gluconate (single dose of 125mg)

Drug: Brand sodium ferric gluconate; Drug: Generic sodium ferric gluconate

Generic sodium ferric gluconate then Brand sodium ferric gluconate

EXPERIMENTAL

Crossover trial. Each arm will receive Generic sodium ferric gluconate (single dose of 125mg) then Brand sodium ferric gluconate (single dose of 125mg)

Drug: Brand sodium ferric gluconate; Drug: Generic sodium ferric gluconate

Interventions

Brand sodium ferric gluconate DRUG

brand product

Also known as: Ferrecit

Brand sodium ferric gluconate then Generic sodium ferric gluconate; Generic sodium ferric gluconate then Brand sodium ferric gluconate

Generic sodium ferric gluconate DRUG

generic product

Also known as: generic iron

Brand sodium ferric gluconate then Generic sodium ferric gluconate; Generic sodium ferric gluconate then Brand sodium ferric gluconate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 21714710 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: James Polli
• Organization: University of Maryland Baltimore

jpolli@rx.umaryland.edu

410-465-3466

Study Officials

• James Polli

  U of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 26, 2015
• Study Start: September 15, 2017
• Primary Completion: March 22, 2019
• Study Completion: April 25, 2019
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Locations

US (1)