IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

NCT ID: NCT02399449

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-04-25

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Brand sodium ferric gluconate then Generic sodium ferric gluconate

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

Group Type: EXPERIMENTAL

Brand sodium ferric gluconate

Intervention Type: DRUG

brand product

Generic sodium ferric gluconate

Intervention Type: DRUG

generic product

Generic sodium ferric gluconate then Brand sodium ferric gluconate

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

Group Type: EXPERIMENTAL

Brand sodium ferric gluconate

Intervention Type: DRUG

brand product

Generic sodium ferric gluconate

Intervention Type: DRUG

generic product

Interventions

Brand sodium ferric gluconate

brand product

Intervention Type: DRUG

Generic sodium ferric gluconate

generic product

Intervention Type: DRUG

Other Intervention Names

Ferrecit; generic iron

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

James E Polli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Polli

Role: PRINCIPAL_INVESTIGATOR

U of Maryland

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21714710 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00060573

Identifier Type: -

Identifier Source: org_study_id