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Iron Supplement

IV vs Oral Iron Therapy for Anemia in Pregnancy (EASI-A Trial)

Phase 4
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing if IV iron therapy is better than oral iron therapy for anemia in pregnancy.

Who is the study for?
This trial is for pregnant individuals less than 24 weeks along, with a hemoglobin level between 9.0 and 11.0 indicating iron deficiency anemia but not severe enough to require transfusion or IV therapy yet. They must have a single baby (singleton gestation) and no history of using IV iron in this pregnancy, sickle cell disease, severe organ disease, autoimmune conditions like SLE, or allergies to the study drugs.
What is being tested?
The trial is testing whether starting intravenous (IV) iron therapy with Ferumoxytol during the second trimester is more effective than oral Ferrous Sulfate at improving blood count and quality of life while reducing side effects in pregnant people with iron deficiency anemia.
What are the potential side effects?
Potential side effects may include allergic reactions to the medications used; however specific side effects are not listed here. Generally, IV iron can cause local pain or irritation where injected and both forms of iron might cause gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Secondary study objectives
Adherence
Anemia at Delivery
Anemia resolution
+6 more

Side effects data

From 2017 Phase 4 trial • 296 Patients • NCT01227616
38%
Gastrointestinal disorders
33%
Infections and infestations
31%
Injury, poisoning and procedural complications
29%
General disorders and administration site conditions
21%
Respiratory, thoracic and mediastinal disorders
20%
Musculoskeletal and connective tissue disorders
19%
Vascular disorders
18%
Nervous system disorders
16%
Metabolism and nutrition disorders
15%
Cardiac disorders
11%
Nausea
11%
Diarrhoea
10%
Skin and subcutaneous tissue disorders
9%
Hypotension
9%
Psychiatric disorders
8%
Vomiting
8%
Muscle spasms
8%
Pyrexia
7%
Arteriovenous fistula site complication
7%
Upper respiratory tract infection
7%
Fluid overload
7%
Blood and lymphatic system disorders
7%
Pain in extremity
7%
Hypertension
6%
Abdominal pain
6%
Urinary tract infection
6%
Cough
6%
Hyperkalaemia
6%
Pruritus
6%
Investigations
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Acute respiratory failure
4%
Arteriovenous fistula thrombosis
4%
Arthralgia
4%
Fall
4%
Headache
4%
Anaemia
3%
Mental status changes
3%
Pulmonary oedema
3%
Cardiac failure congestive
3%
Cellulitis
2%
Angina pectoris
2%
Hip fracture
2%
Gastrointestinal haemorrhage
2%
Cardiac arrest
2%
Acute myocardial infarction
2%
Pleural effusion
2%
Cardio-respiratory arrest
1%
Hypoglycaemia
1%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%
Immune system disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferumoxytol
Iron Sucrose

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous IronExperimental Treatment1 Intervention
510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.
Group II: Oral IronActive Control1 Intervention
325mg oral iron (ferrous sulfate) twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
2011
Completed Phase 4
~4380

Find a Location

Who is running the clinical trial?

Auerbach Hematology and OncologyUNKNOWN
Thomas Jefferson UniversityLead Sponsor
463 Previous Clinical Trials
175,644 Total Patients Enrolled

Media Library

Ferrous Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04278651 — Phase 4
Iron-Deficiency Anemia Research Study Groups: Oral Iron, Intravenous Iron
Iron-Deficiency Anemia Clinical Trial 2023: Ferrous Sulfate Highlights & Side Effects. Trial Name: NCT04278651 — Phase 4
Ferrous Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278651 — Phase 4
~15 spots leftby Aug 2025
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