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Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

Primary Purpose

Pregnancy Related, Anemia, Iron Deficiency

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol Injection [Feraheme]
Ferrous Sulfate
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related

Eligibility Criteria

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

Inclusion Criteria:

  1. Pregnant women 18 years old and above
  2. Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20%
  3. Between 24-34 weeks' pregnancy
  4. Singleton pregnancy
  5. Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
  6. Hemodynamically stable

Exclusion Criteria:

  1. Patients unable to give informed consent
  2. Known allergy/hypersensitivity to IV iron
  3. Inflammatory Bowel Disease or history of gastric bypass surgery
  4. Dialysis-dependent Chronic Kidney Disease/ ESRD
  5. Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
  6. Folate/Vitamin B12 deficiency
  7. Known malignancy
  8. Medication allergy to Tylenol (acetaminophen)
  9. Hemoglobin above 12 or less than 7 g/dL
  10. Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc.
  11. Diagnosis of placenta previa

Sites / Locations

  • Stanford University School of Medicine/Lucile Packard Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravenous iron

Oral iron

Arm Description

Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes.

Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin < 9.

Outcomes

Primary Outcome Measures

Mean Change in Hemoglobin value before and after intervention
Hemoglobin is measured as g/dL at enrollment and after the study intervention

Secondary Outcome Measures

Full Information

First Posted
January 31, 2020
Last Updated
December 9, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04253626
Brief Title
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Official Title
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Anemia, Iron Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous iron
Arm Type
Experimental
Arm Description
Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes.
Arm Title
Oral iron
Arm Type
Active Comparator
Arm Description
Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin < 9.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol Injection [Feraheme]
Intervention Description
510mg intravenous ferumoxytol
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate
Intervention Description
325mg oral ferrous sulfate
Primary Outcome Measure Information:
Title
Mean Change in Hemoglobin value before and after intervention
Description
Hemoglobin is measured as g/dL at enrollment and after the study intervention
Time Frame
From the date of randomization to four weeks after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women 18 years old and above Hemoglobin < 11 g/dL, serum ferritin < 30 ug/dL and or transferrin saturation (TSAT) < 20% Between 24-34 weeks' pregnancy Singleton pregnancy Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH Hemodynamically stable Exclusion Criteria: Patients unable to give informed consent Known allergy/hypersensitivity to IV iron Inflammatory Bowel Disease or history of gastric bypass surgery Dialysis-dependent Chronic Kidney Disease/ ESRD Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia Folate/Vitamin B12 deficiency Known malignancy Medication allergy to Tylenol (acetaminophen) Hemoglobin above 12 or less than 7 g/dL Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc. Diagnosis of placenta previa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre Lyell
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine/Lucile Packard Childrens Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

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