Ferumoxytol

Iron Deficiency Anemia, Chronic Kidney Disease

Treatment

4 FDA approvals

20 Active Studies for Ferumoxytol

What is Ferumoxytol

Ferumoxytol

The Generic name of this drug

Treatment Summary

Ferumoxytol is a medication used to treat iron deficiency anemia in adults with chronic kidney disease. It is given through an intravenous injection and is a solution of iron oxide nanoparticles coated in a semi-synthetic carbohydrate shell. The injection is given at a high dose and quickly goes into the bloodstream.

Feridex

is the brand name

image of different drug pills on a surface

Ferumoxytol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Feridex

Ferumoxytol

2008

3

Approved as Treatment by the FDA

Ferumoxytol, otherwise known as Feridex, is approved by the FDA for 4 uses including Chronic Kidney Disease and Chronic Kidney Disease (CKD) .

Chronic Kidney Disease

Chronic Kidney Disease (CKD)

Iron Deficiency Anemia (IDA)

Iron Deficiency Anemia

Effectiveness

How Ferumoxytol Affects Patients

Ferumoxytol is a drug used to measure hemoglobin, serum ferritin, and transferrin saturation levels. It has been shown to be more effective than oral iron in clinical studies. It can also be used as a contrast agent for MRI scans, as it stays in the bloodstream and allows for data collection over a longer period of time. Iron is important for many bodily functions, including oxidation-reduction reactions and enzymes in the mitochondria. Low iron levels can lead to anemia, decreased oxygen delivery, and learning or thermoregulation defects.

How Ferumoxytol works in the body

Feraheme is a drug made of iron covered by a carbohydrate shell. When this drug enters the body, the shell breaks apart and releases iron. This iron is then stored in the body or used to make hemoglobin. Iron is important for many processes in the body including allowing cells to use oxygen and regulating the body's temperature. Feraheme replaces iron stores more effectively than oral iron supplements and can also be used to make MRI images of the body by darkening contrast media-containing structures.

When to interrupt dosage

The measure of Ferumoxytol is contingent upon the diagnosed condition. The amount likewise fluctuates as per the technique of delivery (e.g. Injection - Intravenous or Solution) noted in the table underneath.

Condition

Dosage

Administration

Chronic Kidney Disease

, 30.0 mg/mL, 0.051 mg/mL, 51.0 mg/mL, 11.2 mg/mL

Solution, Intravenous, Solution - Intravenous, , Injection - Intravenous, Injection

Iron Deficiency Anemia

, 30.0 mg/mL, 0.051 mg/mL, 51.0 mg/mL, 11.2 mg/mL

Solution, Intravenous, Solution - Intravenous, , Injection - Intravenous, Injection

Warnings

There are 20 known major drug interactions with Ferumoxytol.

Common Ferumoxytol Drug Interactions

Drug Name

Risk Level

Description

Technetium Tc-99m oxidronate

Major

Ferumoxytol can cause a decrease in the absorption of Technetium Tc-99m oxidronate resulting in a reduced serum concentration and potentially a decrease in efficacy.

3-Aza-2,3-Dihydrogeranyl Diphosphate

Minor

Ferumoxytol can cause a decrease in the absorption of 3-Aza-2,3-Dihydrogeranyl Diphosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.

Calcium Phosphate

Minor

Ferumoxytol can cause a decrease in the absorption of Calcium Phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.

Calcium phosphate dihydrate

Minor

Ferumoxytol can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy.

Dipotassium phosphate

Minor

Ferumoxytol can cause a decrease in the absorption of Dipotassium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.

Ferumoxytol Toxicity & Overdose Risk

Feraheme may cause serious allergic reactions, including anaphylaxis, which were reported in 0.2% of people who used it. Other allergic reactions such as itching, rash, hives, or wheezing were reported in 3.7% of people who used it. It has not been tested to determine if it can cause cancer, and studies have not found it to cause fertility issues in animals. Feraheme may also cause low blood pressure, iron overload, and alterations to MRI imaging, which could last up to 12 weeks after the last dose.

image of a doctor in a lab doing drug, clinical research

Ferumoxytol Novel Uses: Which Conditions Have a Clinical Trial Featuring Ferumoxytol?

118 active studies are currently being conducted to evaluate the effectiveness of Ferumoxytol for the amelioration of Iron deficiency anemia.

Condition

Clinical Trials

Trial Phases

Iron Deficiency Anemia

7 Actively Recruiting

Phase 3, Phase 4, Phase 2, Not Applicable

Chronic Kidney Disease

102 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 4, Phase 3, Early Phase 1

Patient Q&A Section about ferumoxytol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of Feraheme?

"Dizziness, fainting, low blood pressure, injection site reactions, nausea, vomiting, stomach pain, and diarrhea are all possible side effects of this medication."

Answered by AI

What is the brand name for ferumoxytol?

"Feraheme is a drug used to treat iron deficiency anemia. It is given as an injection and works by replacing the iron in the body."

Answered by AI

What is ferumoxytol made of?

"Ferumoxytol is an intravenous iron preparation that is used to treat the anemia of chronic kidney disease (CKD). It is a carbohydrate-coated, superparamagnetic iron oxide nanoparticle. Because there is very little free iron in the preparation, doses of 510 mg have been safely administered in as little as 17 seconds."

Answered by AI

What is ferumoxytol injection for?

"Ferumoxytol is an iron replacement product that is injected to treat iron deficiency anemia in patients with chronic kidney disease or who have not had success with taking oral iron supplements in the past."

Answered by AI

Clinical Trials for Ferumoxytol

Image of International Diabetes Center in Minneapolis, United States.

Sotagliflozin for Type 1 Diabetes

18 - 75
All Sexes
Minneapolis, MN

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors. 4. Gather information on how participants and clinicians like and use the CGM/CKM reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on the usefulness of CGM/CKM reports

Phase 2
Waitlist Available

International Diabetes Center

Richard Bergenstal, MD

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Velocity pAVF System for Kidney Failure

18 - 80
All Sexes
Dothan, AL

This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used. The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis. The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years. Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.

Recruiting
Has No Placebo

Trinity Research Group (+9 Sites)

Venova Medical

Image of University of Alabama at Birmingham in Birmingham, United States.

Empagliflozin for Chronic Kidney Disease

2 - 17
All Sexes
Birmingham, AL

This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year. Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Phase 3
Recruiting

University of Alabama at Birmingham (+33 Sites)

Boehringer Ingelheim

Image of Centre hospitalier affilié universitaire régional de Trois-Rivières in Trois-Rivières, Canada.

Endoscopic Evaluation for Iron-Deficiency Anemia

18 - 90
All Sexes
Trois-Rivières, Canada

This is a single-center, randomized pilot study evaluating the feasibility and safety of two management strategies for patients on antithrombotic therapy who present with obscure gastrointestinal bleeding (OGIB). Participants will be randomized to either repeated endoscopic evaluations or a conservative medical approach with limited testing. The study aims to assess whether conservative management yields similar clinical outcomes and quality of life compared to standard repeated endoscopic procedures. Results will inform the design of a larger trial and address the current lack of guidelines for managing recurrent iron-deficiency anemia in this patient population.

Recruiting
Has No Placebo

Centre hospitalier affilié universitaire régional de Trois-Rivières

Éva Mathieu, PhD

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Vicadrostat + Empagliflozin for Chronic Kidney Disease

18+
All Sexes
West Hills, CA

This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants are in the study for about 4.5 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine. The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.

Phase 2
Recruiting

Focus Clinical Research (+21 Sites)

Boehringer Ingelheim

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