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Iron Supplement
IV vs Oral Iron for Iron-Deficiency Anemia
Phase 3
Recruiting
Research Sponsored by Auerbach Hematology Oncology Associates P C
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will compare the efficacy of oral versus intravenous iron therapy for the treatment of iron deficiency anemia in the post-bariatric surgical patient.
Who is the study for?
This trial is for adults over 18 who've had Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy at least 3 months ago and are now facing iron deficiency anemia. It's not for those with iron utilization disorders, planned surgeries during the study, pregnant/nursing women, liver issues, multiple allergies, active infections, recent IV iron treatments or known hypersensitivity to the drugs tested.Check my eligibility
What is being tested?
The study compares oral ferrous sulfate tablets with intravenous (IV) Ferumoxytol in treating post-operative bariatric surgery patients with iron deficiency anemia. Participants will be randomly assigned to one of these two treatments and monitored for efficacy and speed of response over a period that includes a primary outcome measure at 6 weeks and follow-up at 12 months.See study design
What are the potential side effects?
Oral ferrous sulfate can cause gastric irritation, nausea, epigastric discomfort, constipation while IV Ferumoxytol may lead to infusion reactions. Side effects vary by individual; some might experience none while others could have more severe reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins.
Change in hemoglobin concentration
Secondary outcome measures
Change in Transferrin saturation (TSAT) >19%
Change in ferritin > 20%
Quality of Life by visual linear analog scale (LASA)
Trial Design
2Treatment groups
Active Control
Group I: Oral IronActive Control4 Interventions
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
Group II: IV IronActive Control4 Interventions
The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.
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Who is running the clinical trial?
Auerbach Hematology Oncology Associates P CLead Sponsor
4 Previous Clinical Trials
336 Total Patients Enrolled
AMAG Pharmaceuticals, Inc.Industry Sponsor
43 Previous Clinical Trials
11,262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that causes too much iron to build up in your body or makes it hard for your body to use iron.You have severe liver cirrhosis or active hepatitis with very high liver enzyme levels.You have a history of being allergic to two or more things.You have a current infection, as indicated by high levels of White Blood Cells and C-Reactive Protein.You have received intravenous iron treatment for iron deficiency anemia in the past.You are allergic to ferumoxytol, oral iron, or any ingredients in the medications.You have had a certain type of weight loss surgery at least 3 months ago.You are 18 years old or older.You have low iron levels or anemia, as indicated by specific blood test results.Your blood tests show high levels of ferritin or transferrin saturation.You have rheumatoid arthritis with ongoing inflammation symptoms.You have received iron treatment or a blood transfusion within the last 4 weeks before the screening or treatment visit.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Iron
- Group 2: IV Iron
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Iron-Deficiency Anemia Patient Testimony for trial: Trial Name: NCT04268849 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers still being sought for this clinical trial?
"This is an active recruitment trial, according to the information available on clinicaltrials.gov. The study was posted on 2/27/2020, with the most recent update taking place on 2/16/2022."
Answered by AI
Could you please explain what intravenous iron is commonly used to treat?
"IV Iron is frequently used to remedy a vitamin a deficiency. Additionally, it is sometimes used to mitigate the effects of anemia, vitamin deficiency, and catarrh."
Answered by AI
Could you please give an estimate of how many people are participating in this clinical trial?
"That is correct, the clinicaltrials.gov website does show that this study is actively recruiting patients. This specific study was posted on February 27th, 2020 and was updated as recently as February 16th, 2022. Currently, they are looking to enroll 104 participants from a single site."
Answered by AI
When was the last time IV Iron was cleared by the FDA?
"IV Iron has been found to be safe in Phase 3 trials, meaning that it has undergone multiple rounds of testing with positive results."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
Auerbach Hematology and Oncology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I'm post bariatric with iron deficiency.
PatientReceived 2+ prior treatments
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