IDA in the Post-bariatric Surgical PatientNCT03777514
Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient
A study testing Ferumoxytol, Ferrous sulfate and Oral vitamin C in people with IDA in the Post-bariatric Surgical Patient, run by Johns Hopkins University.
Trial summary
The aim of the 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 iron deficiency anemia (IDA) in the post-operative bariatric surgical patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDA in the Post-bariatric Surgical Patient
- What is being tested?
- Ferumoxytol, Ferrous sulfate and Oral vitamin C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 < 20 mcg/l, transferrin saturation (TSAT) < 19%, or anemia with Hgb < 13 g/dL for both males and females.
- Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post menopausal or use one of the following contraceptives during the whole study period and after the study has ended for at least five times the plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).
- 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 (ALT > 3 times upper limit of normal)
- Serum ferritin > 500 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
- 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
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
The aim of the 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 iron deficiency anemia (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.
Read the detailed description
Rationale for study: The preponderance of published evidence reports superior efficacy and decreased toxicity of intravenous iron compared to oral iron in correcting anemia and iron parameters in published trials of bariatric surgery patients. Intravenous, and not oral, iron ensures adequate delivery and avoids gastrointestinal toxicities, which may be especially burdensome in these patients who require optimal levels of energy to maintain prudent exercise programs recommended by patients' bariatric practitioners. Uncontradicted published evidence reports safety and efficacy of complete replacement doses of intravenous iron administered in one or two doses of either low molecular weight iron dextran, ferumoxytol, ferric carboxymaltose or iron isomaltoside. A common feature of all studies extant is the lack of reported serious adverse events. Even in patients with minimally invasive procedures such as gastric banding or stapling in whom oral iron may be tolerated, given the often present multiple gastrointestinal perturbations, intravenous iron may simplify care.
Drugs used: The investigators propose to use and FDA approved IV iron preparation - ferumoxytol, administered as two doses (over a interval of 2 to 7 days), each 510 mg over fifteen minutes based on published prospective safety and efficacy data and compare the effectiveness of the treatment to the American Metabolic and Bariatric Associations recommended treatment for iron deficiency anemia in the post-operative bariatric patients of oral iron ferrous sulphate 325 mg twice daily for 6 weeks.
- Being tested
- Ferumoxytol, Ferrous sulfate, Oral vitamin C, Intravenous normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
treatment of iron deficiency anemia with IV iron.
Ferrous sulfateDrug
treatment of iron deficiency anemia with oral iron
Oral vitamin COther
Oral vitamin C to be used as a placebo for participants receiving IV iron
Intravenous normal salineOther
Intravenous normal saline will be used as placebo for participants receiving oral iron
| Study group | Role | What they receive |
|---|---|---|
| IV iron | Active comparator | Ferumoxytol intravenous (IV) 1020 mg as - 2 vials of 510 mg (510 mg IV over 15 minutes) each given 2-7 days apart.
Participants in this group will also receive oral vitamin C as a placebo. Receives: Drug: Ferumoxytol; Other: Oral vitamin C |
| oral iron | Active comparator | Ferrous sulfate 325 mg (oral) tabs morning and evening. Participants in this group will also receive intravenous normal saline as a placebo. Receives: Drug: Ferrous sulfate; Other: Intravenous normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of anemia in oral vs. IV iron as assessed by Clinical Global Impression (CGI) - 2 score
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse
Measured: 6 weeks
Resolution of anemia in oral vs. IV iron as assessed by ferritin level
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by the ferritin level. Ferritin > 20% will be the cutoff for resolution of anemia.
Measured: 6 weeks
Resolution of anemia in oral vs. IV iron as assessed by TSAT
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by TSAT level. TSAT > 19% will be the cutoff for resolution of anemia.
Measured: 6 weeks
Time (weeks) to treatment response as assessed by CGI-2 score
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse. This will be used in assessing the time in weeks when participant noticed a change after receiving treatment.
Measured: 6 weeks
Time (weeks) to treatment response as assessed by ferritin level
Participants will be assessed after six weeks to identify what time (in weeks) ferritin level was > 20% following the treatment with oral or IV iron
Measured: 6 weeks
Time (weeks) to treatment response as assessed by TSAT
Participants will be assessed after six weeks to identify what time (in weeks) TSAT level was > 19% following the treatment with oral or IV iron
Measured: 6 weeks
Secondary outcomes (2)
Need for continued treatment as assessed by ferritin level
Participants will be assessed after a year to see if participants require continued treatment following the treatment with oral or IV iron. This will be determined by the ferritin level. Ferritin > 20% will be the cutoff for no further need for treatment.
Measured: 1 year
Need for continued treatment as assessed by TSAT
Participants will be assessed after a year to see if participants require continued treatment following the treatment with oral or IV iron. This will be determined by TSAT level. TSAT > 19% will be the cutoff for no further need for treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study startAug 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Study wasn't started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDA in the Post-bariatric Surgical PatientStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, comparative double blind, double dummy study to evaluate efficacy and time course of treatment response of bariatric surgical patients found to have IDA, three months or greater following bariatric surgery (Roux-en Y gastric bypass and vertical sleeve gastrectomy) over 6 weeks with a 46-week follow-up extension. Two medications and placebos will be used with equal random assignment to both groups * Ferumoxytol intravenous (IV) 1020 mg as - 2 vials of 510 mg (510 mg IV over 15 minutes) each given 2-7 days apart. * Ferrous sulfate 325 mg (oral) tabs morning and evening. * Placebo: oral vitamin C 500 mg tabs, saline infusion
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Kimberley E Steele, MD, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777514
- Sponsor's protocol ID
- IRB00198735
- Status last verified
- Sep 2019
- First submitted
- 14 Dec 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. 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
- NCT03777514
- Acronym / sponsor ID
- IRB00198735
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study wasn't started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- Aug 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Dec 2018 (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.
The aim of the 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 iron deficiency anemia (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.
Detailed description
Rationale for study: The preponderance of published evidence reports superior efficacy and decreased toxicity of intravenous iron compared to oral iron in correcting anemia and iron parameters in published trials of bariatric surgery patients. Intravenous, and not oral, iron ensures adequate delivery and avoids gastrointestinal toxicities, which may be especially burdensome in these patients who require optimal levels of energy to maintain prudent exercise programs recommended by patients' bariatric practitioners. Uncontradicted published evidence reports safety and efficacy of complete replacement doses of intravenous iron administered in one or two doses of either low molecular weight iron dextran, ferumoxytol, ferric carboxymaltose or iron isomaltoside. A common feature of all studies extant is the lack of reported serious adverse events. Even in patients with minimally invasive procedures such as gastric banding or stapling in whom oral iron may be tolerated, given the often present multiple gastrointestinal perturbations, intravenous iron may simplify care.
Drugs used: The investigators propose to use and FDA approved IV iron preparation - ferumoxytol, administered as two doses (over a interval of 2 to 7 days), each 510 mg over fifteen minutes based on published prospective safety and efficacy data and compare the effectiveness of the treatment to the American Metabolic and Bariatric Associations recommended treatment for iron deficiency anemia in the post-operative bariatric patients of oral iron ferrous sulphate 325 mg twice daily for 6 weeks.
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
- The study is a randomized, comparative double blind, double dummy study to evaluate efficacy and time course of treatment response of bariatric surgical patients found to have IDA, three months or greater following bariatric surgery (Roux-en Y gastric bypass and vertical sleeve gastrectomy) over 6 weeks with a 46-week follow-up extension. Two medications and placebos will be used with equal random assignment to both groups * Ferumoxytol intravenous (IV) 1020 mg as - 2 vials of 510 mg (510 mg IV over 15 minutes) each given 2-7 days apart. * Ferrous sulfate 325 mg (oral) tabs morning and evening. * Placebo: oral vitamin C 500 mg tabs, saline infusion
| Arm | Type | Receives |
|---|---|---|
| IV iron | Active comparator | Drug: Ferumoxytol, Other: Oral vitamin CFerumoxytol intravenous (IV) 1020 mg as - 2 vials of 510 mg (510 mg IV over 15 minutes) each given 2-7 days apart. Participants in this group will also receive oral vitamin C as a placebo. |
| oral iron | Active comparator | Drug: Ferrous sulfate, Other: Intravenous normal salineFerrous sulfate 325 mg (oral) tabs morning and evening. Participants in this group will also receive intravenous normal saline as a placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 < 20 mcg/l, transferrin saturation (TSAT) < 19%, or anemia with Hgb < 13 g/dL for both males and females.
- Willingness to use contraceptive to avoid pregnancy: Women have to be surgically sterile, post menopausal or use one of the following contraceptives during the whole study period and after the study has ended for at least five times the plasma biological half-life of the investigational medicinal product: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release).
- 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 (ALT > 3 times upper limit of normal)
- Serum ferritin > 500 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 |
|---|---|---|
| Ferumoxytoltreatment of iron deficiency anemia with IV iron. | Drug | IV iron |
| Ferrous sulfatetreatment of iron deficiency anemia with oral iron | Drug | oral iron |
| Oral vitamin COral vitamin C to be used as a placebo for participants receiving IV iron | Other | IV iron |
| Intravenous normal salineIntravenous normal saline will be used as placebo for participants receiving oral iron | Other | oral iron |
Primary outcome
Resolution of anemia in oral vs. IV iron as assessed by Clinical Global Impression (CGI) - 2 score
Time frame: 6 weeks
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse
Resolution of anemia in oral vs. IV iron as assessed by ferritin level
Time frame: 6 weeks
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by the ferritin level. Ferritin > 20% will be the cutoff for resolution of anemia.
Resolution of anemia in oral vs. IV iron as assessed by TSAT
Time frame: 6 weeks
Participants will be assessed after six weeks to see if there is a resolution of anemia following the treatment with oral or IV iron. This will be determined by TSAT level. TSAT > 19% will be the cutoff for resolution of anemia.
Time (weeks) to treatment response as assessed by CGI-2 score
Time frame: 6 weeks
The CGI-2 is a one-item questionnaire which asks how participants feel now compared to before receiving treatment. It has a scoring of 1 to 7 with 1 meaning much better and 7 meaning very much worse. This will be used in assessing the time in weeks when participant noticed a change after receiving treatment.
Time (weeks) to treatment response as assessed by ferritin level
Time frame: 6 weeks
Participants will be assessed after six weeks to identify what time (in weeks) ferritin level was > 20% following the treatment with oral or IV iron
Time (weeks) to treatment response as assessed by TSAT
Time frame: 6 weeks
Participants will be assessed after six weeks to identify what time (in weeks) TSAT level was > 19% following the treatment with oral or IV iron
2 secondary outcomes
Need for continued treatment as assessed by ferritin level
Time frame: 1 year
Need for continued treatment as assessed by TSAT
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Kimberley E Steele, MD, Ph.D principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Ferumoxytol, Ferrous sulfate and Oral vitamin C in people with IDA in the Post-bariatric Surgical Patient, run by Johns Hopkins University.
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 5 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: withdrawn, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of anemia in oral vs. IV iron as assessed by Clinical Global Impression (CGI) - 2 score (time frame: 6 weeks). The study lists 6 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 11 Sep 2019.