Ferumoxytol for Iron-Deficiency Anemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new iron treatment called ferumoxytol for children with iron deficiency anemia (IDA) and chronic kidney disease (CKD). Researchers aim to determine if ferumoxytol is safe and more effective than iron sucrose. The study also examines how the body processes ferumoxytol. Children who may qualify for this trial have CKD, low iron levels, and have not responded to oral iron treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ferumoxytol is generally well-tolerated, though some side effects have been observed. Most side effects occurred within 48 hours after treatment and included dizziness and low blood pressure. Importantly, no life-threatening or fatal incidents were reported. While ferumoxytol can cause serious allergic reactions, these are rare.
Iron sucrose, the comparator in this study, has been used for a long time and is generally considered safe. Overall, both ferumoxytol and iron sucrose have shown good tolerance, but like any treatment, they carry potential risks, particularly related to allergic reactions.12345Why do researchers think this study treatment might be promising for CKD?
Ferumoxytol is unique because it offers a new approach to treating iron deficiency anemia (IDA) in kids with chronic kidney disease (CKD). Unlike traditional treatments like iron sucrose, ferumoxytol is an iron oxide nanoparticle that can be administered quickly, potentially reducing the number of hospital visits. Researchers are excited because its fast infusion time and potential for fewer side effects could make managing anemia easier and more comfortable for young patients.
What evidence suggests that this trial's treatments could be effective for pediatric CKD subjects with iron deficiency anemia?
Research has shown that ferumoxytol, one of the treatments studied in this trial, effectively treats iron deficiency anemia (IDA), especially when oral iron supplements are ineffective or unsuitable. Studies have found that ferumoxytol can increase hemoglobin levels, which are crucial for oxygen transport in the blood. One study showed it was more effective than iron sucrose at raising hemoglobin levels in patients. Participants in this trial may receive either ferumoxytol or iron sucrose, the latter being another treatment option under study. Those receiving ferumoxytol have experienced significant improvements in their iron levels. Overall, ferumoxytol appears to be a strong treatment option for individuals with IDA, particularly those with chronic kidney disease (CKD).678910
Are You a Good Fit for This Trial?
This trial is for children with chronic kidney disease who have iron deficiency anemia or are at risk of it. Participants must have tried and not tolerated oral iron, or can't take it. They need to meet certain blood test levels and use birth control if sexually active. Those with severe allergies to IV iron, very low blood pressure, or high ferritin can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ferumoxytol or iron sucrose for the treatment of iron deficiency anemia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ferumoxytol
- Iron Sucrose
Trial Overview
The study compares two intravenous (IV) treatments for iron deficiency anemia in kids with chronic kidney disease: ferumoxytol versus the standard treatment, iron sucrose. The goal is to see which works better and is safer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Ferumoxytol is already approved in United States, European Union, Canada for the following indications:
- Chronic kidney disease-related anemia
- Magnetic resonance imaging contrast agent
- Chronic kidney disease-related anemia
- Magnetic resonance imaging contrast agent
- Chronic kidney disease-related anemia
- Magnetic resonance imaging contrast agent
Find a Clinic Near You
Who Is Running the Clinical Trial?
AMAG Pharmaceuticals, Inc.
Lead Sponsor
Citations
Efficacy and safety of IV ferumoxytol for adults with iron ... - PMC
Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used.
FERAHEME® vs Placebo | Comparative efficacy & safety
FERAHEME is the only IV iron with patient-reported outcome data in the label1. In IDA Trial 1 and the extension trial, just 1 gram of FERAHEME demonstrated: ...
3.
ashpublications.org
ashpublications.org/blood/article/116/21/5151/66638/Efficiency-Outcomes-Associated-with-IncreasedEfficiency Outcomes Associated with Increased Ferumoxytol ...
The clinic estimates that 80% of patients receiving IV iron treatment have reduced kidney function. Ferumoxytol treatment became available in ...
4.
hematologyadvisor.com
hematologyadvisor.com/news/single-dose-ferumoxytol-effective-for-iron-deficiency/Evaluation of Single-Dose Intravenous Infusions ...
The primary efficacy endpoint of the analysis included median changes from baseline in hemoglobin, hematocrit, and ferritin levels 8 to 12 weeks ...
A Phase III, randomized, open-label trial of ferumoxytol ... - PMC
Ferumoxytol was shown to be superior to iron sucrose in the mean increase in Hgb from Baseline to Week 5 (the alternate, preplanned primary efficacy endpoint), ...
Safety and side effects | FERAHEME® (ferumoxytol injection)
Safety and side effects of FERAHEME® in ~2000 iron deficiency anemia patients, including rates of hypersensitivity and hypotension. See Boxed Warning.
Safety Data Sheet (SDS)
Do not take action without suitable protective clothing - see section 8 of SDS. Evacuate personnel to safe areas. Ensure adequate ventilation.
What Does the Boxed Warning Tell Us? Safe Practice of Using ...
Most AEs occurred within 48 hours after ferumoxytol infusion (in 58 cases [8.6% of the infusions]). There were no life-threatening or fatal (grade 4 or 5) AEs.
9.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/MSDS_9ZARSP_FERAHEME_VL_510MG_17ML.pdfMSDS
In clinical trials, patients treated intravenously with high doses of ferumoxytol experienced gastrointestinal effects, dizziness, hypotension ...
Feraheme. - accessdata.fda.gov
Risk Summary. Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.
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