IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

ConditionsAnemia, Iron Deficiency Uterine Bleeding

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorBaylor College of Medicine

About this trial

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sub-acute or chronic uterine blood loss;

Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;

Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;

Eligible for discharge from the ED following treatment;

Disqualifiers

Patient requiring hospitalization for any reason;

Pregnant or nursing;

Incarcerated/Prisoner;

Weight < 50 kg;

Trial design

Design model

Parallel

Treatments tested in this trial

Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
Drug
Single Dose of IV Iron
Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Drug
Once daily by mouth for 42 days

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Intravenous Ferric DerisomaltoseExperimental treatment 1 intervention

Group B: Oral IronActive comparator 1 intervention

Trial outcomes

Primary outcomes

mean change in hemoglobin concentration

participants will have increased hemoglobin concentrations

Time frame

3 weeks

Secondary outcomes

mean change in hemoglobin concentration

participants will have increased hemoglobin concentrations

Time frame

6 weeks

Other outcomes

mean change in ferritin

participants will have increased ferritin

Time frame

3 weeks

mean change in ferritin

participants will have increased ferritin

Time frame

6 weeks

median number of transfusions

compare between the two arms

Time frame

6 weeks

median number of return Emergency Department visits

compare between the two arms

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Pharmacosmos Therapeutics, Inc.

Collaborator

Source ClinicalTrials.gov

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