IV Iron Safety: Evaluation of Iron Species in Healthy Subjects

ClinicalTrials.gov ID: NCT02399449

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Official title

Evaluation of Iron Species in Healthy Subjects Treated With Generic and Reference Sodium Ferric Gluconate

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02399449
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: University of Maryland, Baltimore; Other
Enrollment: 110 participants

Conditions and interventions

Conditions

Anemia

Interventions

Brand sodium ferric gluconate Drug
Generic sodium ferric gluconate Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 15, 2017 (Actual)
Primary completion: Mar 22, 2019 (Actual)
Completion: Apr 25, 2019 (Actual)
Last update posted: Sep 28, 2022

2017 – 2019

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Maryland	Baltimore	Maryland	21201	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02399449, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 28, 2022 · Synced Nov 12, 2026