CompletedNCT02399449Updated Sep 28, 2022Results posted

IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

A Phase 4 interventional study of Brand sodium ferric gluconate and Generic sodium ferric gluconate in Anemia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.

Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Basic science

Phase: Phase 4
Study type: Interventional
Enrollment: 110
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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 studied

Anemia

Keywords

iron
pharmacokinetics

In context

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: 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

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.

Study design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 110 participants (actual)

Study arms

Experimental
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)
Drug: Brand sodium ferric gluconate · Drug: Generic sodium ferric gluconate
Experimental
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)
Drug: Brand sodium ferric gluconate · Drug: Generic sodium ferric gluconate

Interventions

DrugBrand sodium ferric gluconate
brand product
Also known as: Ferrecit
DrugGeneric sodium ferric gluconate
generic product
Also known as: generic iron

What researchers measure

Primary outcomes

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).
Time frame: 0-36 hr

Secondary outcomes

Plasma Total Iron
area under curve of plasma total iron. Units are concentration x time (i.e. ppb x hr).
Time frame: 0-36 hr
Transferrin Bound Iron
area under curve of transferrin bound iron. Units are concentration x time (i.e. ppb x hr).
Time frame: 0-36 hr

Results

Posted Sep 28, 2022

Participant flow

Participant flow — Overall Study
Milestone	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate
Started	25	32
Completed	22	22
Not completed	3	10
Withdrew: Withdrawal by subject	3	9
Withdrew: Physician decision	0	1

Outcome measures

PrimaryNon-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).

Time frame:: 0-36 hr
Reported as:: Mean · ppb x hours

Non-transferrin Bound Iron
ppb x hours	Brand Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate
Non-transferrin Bound Iron	56230 ± 2910	61250 ± 3410

SecondaryPlasma Total Iron

area under curve of plasma total iron. Units are concentration x time (i.e. ppb x hr).

Time frame:: 0-36 hr
Reported as:: Mean · ppb x hours

Plasma Total Iron
ppb x hours	Brand Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate
Plasma Total Iron	132800 ± 4700	134700 ± 5100

SecondaryTransferrin Bound Iron

area under curve of transferrin bound iron. Units are concentration x time (i.e. ppb x hr).

Time frame:: 0-36 hr
Reported as:: Mean · ppb x hours

Transferrin Bound Iron
ppb x hours	Brand Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate
Transferrin Bound Iron	96760 ± 3680	91740 ± 3980

Adverse events

Collected over About 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Brand Sodium Ferric Gluconate	0/47 (0%)	1/47 (2.1%)	13/47 (27.7%)
Generic Sodium Ferric Gluconate	0/46 (0%)	0/46 (0%)	3/46 (6.5%)

Most frequent serious events

Most frequent serious events
Event	Brand Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate
hypotensionVascular disorders	1/47	0/46

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Brand Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate
Lower Back PainGeneral disorders	7/47	0/46
DizzinessNervous system disorders	4/47	0/46
Abdominal CrampingGeneral disorders	3/47	0/46
HypotensionVascular disorders	3/47	0/46
Infusion Site IrritationSkin and subcutaneous tissue disorders	0/47	2/46
DyspneaRespiratory, thoracic and mediastinal disorders	2/47	0/46
Hand SwellingGeneral disorders	2/47	0/46
Hand Muscle StiffnessMusculoskeletal and connective tissue disorders	2/47	0/46
Infusion Site PainGeneral disorders	0/47	1/46
Leg SwellingGeneral disorders	1/47	0/46

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate	Total
<=18 years	0	0	0
Between 18 and 65 years	25	24	49
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate	Total
Mean	34 (22 to 56)	36 (22 to 54)	35 (22 to 56)

Sex: Female, Male
Sex: Female, Male(Participants)	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate	Total
Female	11	12	23
Male	14	12	26

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate	Total
American Indian or Alaska Native	0	0	0
Asian	3	3	6
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	8	7	15
White	7	12	19
More than one race	7	2	9
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Brand Sodium Ferric Gluconate Then Generic Sodium Ferric Gluconate	Generic Sodium Ferric Gluconate Then Brand Sodium Ferric Gluconate	Total
United States	25	24	49

Study locations

1 site

University of Maryland
Baltimore, Maryland 21201, United States

References and documents

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. PubMed 21714710 ↗

Study documents

Protocol and statistical analysis plan · Apr 10, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02399449
Lead sponsor: University of Maryland, Baltimore
Responsible party: James E Polli (Professor, University of Maryland, Baltimore) — Principal investigator
First posted: Mar 26, 2015
Start date: Sep 15, 2017
Primary completion: Mar 22, 2019
Completion: Apr 25, 2019
Results posted: Sep 28, 2022
Last update: Sep 28, 2022

Study contacts

James Polli

principal investigator · U of Maryland

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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