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

NCT03777514 | Withdrawn DMC

• 1 other identifier: IRB00198735
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IDA in the Post-bariatric Surgical Patient

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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

  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

  6 weeks

Secondary Outcomes (2)

• Need for continued treatment as assessed by ferritin level

  1 year

• Need for continued treatment as assessed by TSAT

  1 year

Study Arms (2)

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.

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.

Drug: Ferrous sulfate; Other: Intravenous normal saline

Interventions

Ferumoxytol DRUG

treatment of iron deficiency anemia with IV iron.

IV iron

Ferrous sulfate DRUG

treatment of iron deficiency anemia with oral iron

oral iron

Oral vitamin C OTHER

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

IV iron

Intravenous normal saline OTHER

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

oral iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 \< 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• AMAG Pharmaceuticals, Inc.: collaborator

MeSH Terms

Interventions

Ferrosoferric Oxide; ferrous sulfate; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Kimberley E Steele, MD, Ph.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: August 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: September 1, 2022
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share