Ferumoxytol for Iron Deficiency Anemia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Iron Deficiency Anemia+2 MoreFerumoxytol - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Iron Deficiency Anemia
  • Pregnancy
  • Anemia of Pregnancy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 9 months

30, 60, 90 days
Quality of life scale
9 months
Anemia at Delivery
Need for additional therapy
Need for post partum transfusion
Neonatal outcomes gestational age of delivery (weeks)
Neonatal outcomes: birth weight
Umbilical Cord Blood
90 days
Adherence
Anemia resolution
Body Weight Changes

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Iron Sucrose
43%Injury, poisoning and procedural complications
37%Gastrointestinal disorders
34%Infections and infestations
26%Musculoskeletal and connective tissue disorders
25%Vascular disorders
25%Nervous system disorders
22%General disorders and administration site conditions
19%Respiratory, thoracic and mediastinal disorders
19%Cardiac disorders
15%Nausea
15%Metabolism and nutrition disorders
13%Investigations
12%Vomiting
12%Diarrhoea
11%Pain in extremity
10%Skin and subcutaneous tissue disorders
8%Arteriovenous fistula site complication
8%Abdominal pain
7%Non-cardiac chest pain
7%Headache
7%Arteriovenous fistula thrombosis
7%Psychiatric disorders
7%Arthralgia
7%Muscle spasms
7%Hypotension
7%Dizziness
6%Dyspnoea
6%Fall
6%Cellulitis
6%Upper respiratory tract infection
6%Hypertension
6%Fluid overload
6%Blood and lymphatic system disorders
5%Anaemia
5%Cardiac failure congestive
5%Cough
5%Hyperkalaemia
4%Angina pectoris
4%Pruritus
3%Pneumonia
3%Acute myocardial infarction
3%Hypoglycaemia
3%Urinary tract infection
2%Sepsis
2%Acute respiratory failure
2%Cardiac arrest
2%Pulmonary oedema
2%Ear and labyrinth disorders
1%Immune system disorders
1%Gastrointestinal haemorrhage
1%Cardio-respiratory arrest
1%Mental status changes
1%Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%Pyrexia
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01227616) in the Iron Sucrose ARM group. Side effects include: Injury, poisoning and procedural complications with 43%, Gastrointestinal disorders with 37%, Infections and infestations with 34%, Musculoskeletal and connective tissue disorders with 26%, Vascular disorders with 25%.

Trial Design

2 Treatment Groups

Oral Iron
1 of 2
Intravenous Iron
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Ferumoxytol · No Placebo Group · Phase 4

Intravenous Iron
Drug
Experimental Group · 1 Intervention: Ferumoxytol · Intervention Types: Drug
Oral Iron
Drug
ActiveComparator Group · 1 Intervention: Ferrous Sulfate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iron
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months

Who is running the clinical trial?

Auerbach Hematology and OncologyUNKNOWN
Thomas Jefferson UniversityLead Sponsor
407 Previous Clinical Trials
135,429 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a baseline hemoglobin level of 9.0 to 11.
Ferritin is less than 30 ng/mL and/or TIBS is less than 20%.

Who else is applying?

What state do they live in?
Utah100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Thomas Jefferson University Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%