Comparing IV and oral iron treatments for anemia after bariatric surgery

A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

This study is testing whether IV iron or oral iron supplements work better to help adults with iron deficiency anemia after bariatric surgery feel healthier.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Auerbach Hematology Oncology Associates P C (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04268849 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intravenous (IV) iron treatment compared to oral iron supplements in patients suffering from iron deficiency anemia following bariatric surgery, specifically Roux-en-Y gastric bypass and vertical sleeve gastrectomy. Given the high prevalence of iron deficiency anemia in post-operative bariatric patients, the study aims to determine which method provides better outcomes in correcting anemia. Participants will be monitored for improvements in iron levels and overall health after receiving either treatment. The trial includes adults who are at least three months post-surgery and meet specific criteria for iron deficiency.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone Roux-en-Y gastric bypass or vertical sleeve gastrectomy and are experiencing iron deficiency anemia.

Not a fit: Patients with iron overload conditions, active infections, or significant liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for iron deficiency anemia in post-bariatric surgery patients, improving their overall health and quality of life.

How similar studies have performed: Other studies have shown varying success with different iron supplementation methods in similar patient populations, but this specific comparison of IV versus oral iron in post-bariatric patients is relatively novel.

Eligibility criteria

Inclusion criteria:

1. Aged ≥ 18 years
2. Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery.
3. Iron deficiency anemia defined as iron deficient with either ferritin\<30 mcg/l, TSAT\<20%, or anemia with Hgb\<13 g/dL for both males and females.
4. Willingness to participate and signing the informed consent form.

Exclusion criteria:

1. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
2. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
3. Serum ferritin \> 400 ng/mL or transferrin saturation \>40 %
4. Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available)
5. Rheumatoid arthritis with symptoms or signs of active inflammation
6. Pregnant and nursing women
7. History of multiple allergies (two or more)
8. Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products
9. Previous IV iron treatment for IDA
10. Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
11. Planned elective surgery during the study
12. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus

Where this trial is running

Baltimore, Maryland

• Auerbach Hematology and Oncology — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Michael Auerbach, MD

Conditions Iron Deficiency Anemia; Bariatric Surgery; Roux-en-Y gastric bypass; Vertical Sleeve Gastrectomy