Iron Deficiency AnemiaPhase 3NCT04268849
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
A Phase 3 study testing Ferumoxytol, Saline and Ferrous sulfate tablets in people with Iron Deficiency Anemia, run by Auerbach Hematology Oncology Associates P C at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferumoxytol, Saline and Ferrous sulfate tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to Feb 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Auerbach Hematology and Oncology
Baltimore, Maryland, 21237
Michael Auerbach, MD, 410-780-4050, mauerbachmd@abhemonc.com
About this study
Official title: A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
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).
Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient.
Read more
The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient.
The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.
The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferumoxytol, Saline, Ferrous sulfate tablets, Vitamin C
- Keywords
- Bariatric Surgery, Roux-en-Y gastric bypass (RYGB), Vertical Sleeve Gastrectomy (VSG)
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Ferumoxytol (30 mg/mL) intravenous injection in single use vials.
SalineDrug
Placebo for Ferumoxytol
Ferrous sulfate tabletsDrug
ferrous sulfate tablets containing 60 mg elemental iron
Vitamin CDrug
Placebo: Vitamin C, 250 mg, given in the same bottle as the oral iron
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron | Active comparator | 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. Receives: Drug: Ferumoxytol; Drug: Saline; Drug: Ferrous sulfate tablets; Drug: Vitamin C |
| IV Iron | Active comparator | 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. Receives: Drug: Ferumoxytol; Drug: Saline; Drug: Ferrous sulfate tablets; Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins.
The CGI-2 is a measure of treatment response and the efficacy of the treatment based on a 1 to 7 scale where 1 is "very much better" and 7 "very much worse"
Measured: 6 weeks
Change in hemoglobin concentration
Measured: 6 weeks
Secondary outcomes (3)
Change in ferritin > 20%
Measured: 6 weeks
Change in Transferrin saturation (TSAT) >19%
Measured: 6 weeks
Quality of Life by visual linear analog scale (LASA)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start27 Feb 2020
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, double dummy of oral versus intravenous iron for iron deficiency patients after bariatric surgery. All subjects will get either oral iron and intravenous saline, or oral vitamin C and intravenous iron.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auerbach Hematology Oncology Associates P C
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Michael Auerbach MD, Auerbach Hematology Oncology Associates P C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268849
- Sponsor's protocol ID
- BariatricsProtocol100719
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- ClinicalTrials.gov ID
- NCT04268849
- Acronym / sponsor ID
- BariatricsProtocol100719
- Conditions
- Iron Deficiency Anemia
- Keywords
- Bariatric Surgery, Roux-en-Y gastric bypass (RYGB), Vertical Sleeve Gastrectomy (VSG)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Auerbach Hematology Oncology Associates P CUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient.
The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for its caustic effects on the gastric mucosa causing gastric irritation, nausea, epigastric discomfort and constipation. These debilitating symptoms lead to poor adherence and lower long and short-term efficacy. Furthermore, iron absorption from oral iron supplements when taken with food in patients with low iron stores ranges from 2 to 13% and without food 5 to 28%. An alternative and more effective method of iron replenishment is the use of intravenous iron. A litany of published trials, without contradiction, show marked superiority of intravenous iron in improving hemoglobin concentrations and iron parameters when compared to historical controls. Nonetheless, the current recommendations of the American Society of Metabolic and Bariatric Surgery nutritional guidelines, state that oral iron supplementation for IDA is the recommended first line of treatment. Studies are lacking that compare the efficacy of oral versus intravenous (IV) iron therapy for the treatment of IDA in the post-bariatric surgical patient.
The aim of our study is to compare two accepted treatments for iron deficiency anemia (oral ferrous sulfate and intravenous ferumoxytol) for efficacy and speed of response in the treatment of IDA in the post-operative bariatric surgical patient. In this study, 104 bariatric surgical post-operative patients will be randomly assigned 52 each to oral or 52 to a single dose IV iron treatment using double-blind procedures.
The primary outcome will be determined at 6 weeks of treatment with a follow-up at 12 months after treatment. Non-responders at 6 weeks after treatment may, if they qualify (based on inclusion/exclusion criteria), have an open-label IV iron treatment and will be followed with the same evaluations used after the first IV iron treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, double dummy of oral versus intravenous iron for iron deficiency patients after bariatric surgery. All subjects will get either oral iron and intravenous saline, or oral vitamin C and intravenous iron.
| Arm | Type | Receives |
|---|---|---|
| Oral Iron | Active comparator | Drug: Ferumoxytol, Drug: Saline, Drug: Ferrous sulfate tablets, Drug: Vitamin CThe 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. |
| IV Iron | Active comparator | Drug: Ferumoxytol, Drug: Saline, Drug: Ferrous sulfate tablets, Drug: Vitamin CThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolFerumoxytol (30 mg/mL) intravenous injection in single use vials. | Drug | IV Iron, Oral Iron |
| SalinePlacebo for Ferumoxytol | Drug | IV Iron, Oral Iron |
| Ferrous sulfate tabletsferrous sulfate tablets containing 60 mg elemental iron | Drug | IV Iron, Oral Iron |
| Vitamin CPlacebo: Vitamin C, 250 mg, given in the same bottle as the oral iron | Drug | IV Iron, Oral Iron |
Primary outcome
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins.
Time frame: 6 weeks
The CGI-2 is a measure of treatment response and the efficacy of the treatment based on a 1 to 7 scale where 1 is "very much better" and 7 "very much worse"
Change in hemoglobin concentration
Time frame: 6 weeks
3 secondary outcomes
Change in ferritin > 20%
Time frame: 6 weeks
Change in Transferrin saturation (TSAT) >19%
Time frame: 6 weeks
Quality of Life by visual linear analog scale (LASA)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferumoxytol, Saline and Ferrous sulfate tablets in people with Iron Deficiency Anemia, run by Auerbach Hematology Oncology Associates P C at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Auerbach, MD (4107804050, mauerbachmd@abhemonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins. (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.