IV Iron for Iron-Deficiency Anemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Auerbach Hematology and Oncology, Baltimore, MDIron-Deficiency AnemiaFerumoxytol - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial will compare the efficacy of oral versus intravenous iron therapy for the treatment of iron deficiency anemia in the post-bariatric surgical patient.

Eligible Conditions
  • Iron-Deficiency Anemia

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 6 weeks

6 weeks
Change in Clinical Global Impression - improvement scale (CGI-2) score at 6 weeks after treatment begins.
Change in Transferrin saturation (TSAT) >19%
Change in ferritin > 20%
Change in hemoglobin concentration
Quality of Life by visual linear analog scale (LASA)

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

IV Iron
1 of 2
Oral Iron
1 of 2

Active Control

104 Total Participants · 2 Treatment Groups

Primary Treatment: IV Iron · No Placebo Group · Phase 3

IV IronActiveComparator Group · 4 Interventions: Ferumoxytol, Saline, Vitamin C, Ferrous sulfate tablets · Intervention Types: Drug, Drug, Drug, Drug
Oral IronActiveComparator Group · 4 Interventions: Ferumoxytol, Saline, Vitamin C, Ferrous sulfate tablets · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Industry Sponsor
43 Previous Clinical Trials
11,310 Total Patients Enrolled
Auerbach Hematology Oncology Associates P CLead Sponsor
4 Previous Clinical Trials
336 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Are volunteers still being sought for this clinical trial?

"This is an active recruitment trial, according to the information available on clinicaltrials.gov. The study was posted on 2/27/2020, with the most recent update taking place on 2/16/2022." - Anonymous Online Contributor

Unverified Answer

Could you please explain what intravenous iron is commonly used to treat?

"IV Iron is frequently used to remedy a vitamin a deficiency. Additionally, it is sometimes used to mitigate the effects of anemia, vitamin deficiency, and catarrh." - Anonymous Online Contributor

Unverified Answer

Could you please give an estimate of how many people are participating in this clinical trial?

"That is correct, the clinicaltrials.gov website does show that this study is actively recruiting patients. This specific study was posted on February 27th, 2020 and was updated as recently as February 16th, 2022. Currently, they are looking to enroll 104 participants from a single site." - Anonymous Online Contributor

Unverified Answer

When was the last time IV Iron was cleared by the FDA?

"IV Iron has been found to be safe in Phase 3 trials, meaning that it has undergone multiple rounds of testing with positive results." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.