Monoferric for Prenatal Iron Deficiency

Last updated: September 16, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Ferric derisomaltose

Clinical Study ID

NCT05763043
OHSU IRB 25397
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants 18 years of age or older between 14 to 42 weeks gestation who aredeemed appropriate for IV iron by their treating provider as part of their standardof 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

Exclusion Criteria:

  • Known infectious, inflammatory, or malignant conditions that may confound ironrepletion and outcome analysis

  • Prior IV iron intolerance or hypersensitivity reaction

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Ferric derisomaltose
Phase: 1
Study Start date:
January 18, 2024
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Oregon Health & Science Univerity

    Portland, Oregon 97239
    United States

    Active - Recruiting

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