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Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

Primary Purpose

IDA in the Post-bariatric Surgical Patient

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Ferumoxytol

Ferrous sulfate

Oral vitamin C

Intravenous normal saline

About this trial

This is an interventional treatment trial for IDA in the Post-bariatric Surgical Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 < 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.

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

IV iron

oral iron

Arm Description

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.

Ferrous sulfate 325 mg (oral) tabs morning and evening. Participants in this group will also receive intravenous normal saline as a placebo.

Outcomes

Primary Outcome Measures

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

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.

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.

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.

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

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03777514

First Posted

December 14, 2018

Last Updated

September 9, 2019

Sponsor

Johns Hopkins University

Collaborators

AMAG Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03777514

Brief Title

Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Study wasn't started.

Study Start Date

August 2019 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

AMAG Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IDA in the Post-bariatric Surgical Patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The IV bags will be opaque and patients will be asked to wear a eye mask during the infusion of iron vs. saline. The oral tables will be identical in color and shape (iron in the form of ferrous sulphate and vitamin C)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV iron

Arm Type

Active Comparator

Arm Description

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.

Arm Title

oral iron

Arm Type

Active Comparator

Arm Description

Ferrous sulfate 325 mg (oral) tabs morning and evening. Participants in this group will also receive intravenous normal saline as a placebo.

Intervention Type

Drug

Intervention Name(s)

Ferumoxytol

Intervention Description

treatment of iron deficiency anemia with IV iron.

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate

Intervention Description

treatment of iron deficiency anemia with oral iron

Intervention Type

Other

Intervention Name(s)

Oral vitamin C

Intervention Description

Oral vitamin C to be used as a placebo for participants receiving IV iron

Intervention Type

Other

Intervention Name(s)

Intravenous normal saline

Intervention Description

Intravenous normal saline will be used as placebo for participants receiving oral iron

Primary Outcome Measure Information:

Title

Resolution of anemia in oral vs. IV iron as assessed by Clinical Global Impression (CGI) - 2 score

Description

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

Time Frame

6 weeks

Title

Resolution of anemia in oral vs. IV iron as assessed by ferritin level

Description

Time Frame

6 weeks

Title

Resolution of anemia in oral vs. IV iron as assessed by TSAT

Description

Time Frame

6 weeks

Title

Time (weeks) to treatment response as assessed by CGI-2 score

Description

Time Frame

6 weeks

Title

Time (weeks) to treatment response as assessed by ferritin level

Description

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 Frame

6 weeks

Title

Time (weeks) to treatment response as assessed by TSAT

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Need for continued treatment as assessed by ferritin level

Description

Time Frame

1 year

Title

Need for continued treatment as assessed by TSAT

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 < 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. Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberley E Steele, MD, Ph.D

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intravenous (IV) Versus Oral Iron Treatment of Iron Deficiency Anemia in the Post-operative Bariatric Surgical Patient

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