Monoferric for Prenatal Iron Deficiency

NCT05763043 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: OHSU IRB 25397
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstetric Labor Complications

Outcome Measures

Primary Outcomes (1)

• The proportion of participants who experienced a resolution of iron deficiency anemia

  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

Study Arms (1)

Ferric derisomaltose

EXPERIMENTAL

Drug: Ferric derisomaltose

Interventions

Ferric derisomaltose DRUG

Participants between the gestational ages of 14 to 42 weeks with iron deficiency will receive IV Ferric derisomaltose at a routine prenatal visit.

Also known as: Monoferric

Ferric derisomaltose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science Univerity

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Women's Health Research Unit Research Unit Department of OB/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: January 18, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)