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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
EASI-A Trial 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.Check my eligibility
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.See study design
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.
EASI-A Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Secondary outcome measures
Adherence
Anemia at Delivery
Anemia resolution
+6 moreSide effects data
From 2017 Phase 4 trial • 296 Patients • NCT0122761638%
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%
Blood and lymphatic system disorders
7%
Fluid overload
7%
Pain in extremity
7%
Hypertension
6%
Urinary tract infection
6%
Hyperkalaemia
6%
Investigations
6%
Pruritus
6%
Abdominal pain
6%
Cough
6%
Dyspnoea
6%
Pneumonia
5%
Sepsis
5%
Non-cardiac chest pain
5%
Dizziness
4%
Arteriovenous fistula thrombosis
4%
Fall
4%
Acute respiratory failure
4%
Arthralgia
4%
Headache
4%
Anaemia
3%
Pulmonary oedema
3%
Mental status changes
3%
Cardiac failure congestive
3%
Cellulitis
2%
Angina pectoris
2%
Gastrointestinal haemorrhage
2%
Hip fracture
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
EASI-A 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
445 Previous Clinical Trials
145,409 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously received intravenous iron during this pregnancy.You have severe anemia and need a blood transfusion or IV iron therapy.You have serious heart, kidney, or liver problems.Your blood test shows that you have mild anemia and low iron levels.You have had a bad reaction to medications given through an IV, or to Feraheme or other IV iron products.You have been diagnosed with iron deficiency anemia, which means your blood has low levels of hemoglobin or ferritin or total iron saturation.You were born with a major genetic or chromosomal condition.Your ferritin level is below 30 or your total iron saturation is below 20.You have sickle cell disease, not just the trait.You are less than 24 weeks pregnant.The participant is pregnant with only one baby.You have an autoimmune disease like systemic lupus erythematosus (SLE).Your hemoglobin level is less than 11.0.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Iron
- Group 2: Intravenous Iron
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I join this clinical experiment?
"To qualify for this clinical investigation, individuals must have anemia and iron deficiency as well as be between the ages of 18 to 65. This particular trial is expecting around 80 participants."
Answered by AI
What is the common application of Ferumoxytol?
"Ferumoxytol is typically administered to breastfeeding mothers, but can also be helpful in addressing folic acid deficiency, iron deficiencies, and inadequate dietary intake."
Answered by AI
Are there any precedents of Ferumoxytol being used in clinical trials?
"Presently, 35research initiatives related to Ferumoxytol are ongoing, with 7 of them in the third phase. Kano and Lagos have the highest concentration of studies for this medication but there are 154 sites worldwide conducting trials on it."
Answered by AI
Is this research currently in need of volunteers?
"Affirmative. Clinicaltrials.gov records indicate that this medical study, first published on September 29th 2021, is actively looking for prospective candidates. The research requires 80 patients to be recruited from 1 sites."
Answered by AI
How many individuals can take part in this clinical experiment?
"Affirmative. Clinicaltrials.gov documents the ongoing recruitment for this medical trial which was initiated on September 29th 2021 and recently updated on February 4th 2022. 80 people are sought out to join from a single research facility."
Answered by AI
What possible hazards could be associated with Ferumoxytol consumption?
"Ferumoxytol is highly regarded for its safety, warranting it a score of 3. This medication has gone through the full gamut of clinical trials and received approval by regulatory authorities."
Answered by AI
Does this research encompass persons aged 40 or older?
"This trial is designed for participants aged 18 to 65. For those younger and older, there are 137 studies for patients under 18 and 282 involving individuals above the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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