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Compares treatment options for Iron Deficiency Anemia
Official title Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
ClinicalTrials.gov ID: NCT04268849
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for iron deficiency anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG).
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years
- 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.
- 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.
- Willingness to participate and signing the informed consent form.
You likely can't join if
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
- Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
- Serum ferritin \> 400 ng/mL or transferrin saturation \>40 %
- Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when...
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Pregnant and nursing women
See the full eligibility criteria
- Aged ≥ 18 years
- 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.
- 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.
- Willingness to participate and signing the informed consent form.
- Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)
- Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
- Serum ferritin \> 400 ng/mL or transferrin saturation \>40 %
- 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)
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Pregnant and nursing women
- History of multiple allergies (two or more)
- Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products
- Previous IV iron treatment for IDA
- Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit
- Planned elective surgery during the study
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.