Monoferric for Prenatal Iron Deficiency

September 16, 2024 updated by: Ashley Benson, Oregon Health and Science University
A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Women's Health Research Unit Research Unit Department of OB/Gyn
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science Univerity
        • Contact:
          • Women's Health Research Unit
          • Phone Number: 503-494-3666
          • Email: whru@ohsu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
  • Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
  • Experience intolerance to oral iron or are greater than 28 weeks gestation
  • Willing to participate in the study

Exclusion Criteria:

  • Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
  • Prior IV iron intolerance or hypersensitivity reaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferric derisomaltose
Drug: Ferric derisomaltose
Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.
Other Names:
  • Monoferric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants who experienced a resolution of iron deficiency anemia
Time Frame: From enrollment to 6 weeks post partum
The proportion of participants who experienced a resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at a follow up assessment at 6 weeks postpartum following IV Monoferric administration
From enrollment to 6 weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU IRB 25397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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