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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
No Placebo-Only Group
Pivotal Trial
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins.
Awards & Highlights
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.
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.
Find a Location
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
11,210 Total Patients Enrolled
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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
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