Ferumoxytol for Iron Deficiency Anemia in Kids with CKD

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Recruiting Phase 3 Interventional Study
Chronic Kidney Disease; Iron Deficiency Anemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
129 (estimated)
Sponsor
AMAG Pharmaceuticals, Inc. · Industry
Who this trial is looking for

This trial is looking for children aged 2 to under 18 who have iron deficiency anemia and chronic kidney disease. Participants will receive a treatment to help manage their condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 2 and 17 years old.
  • I have iron deficiency anemia.
  • I have chronic kidney disease.
  • I have not responded to oral iron therapy or cannot take it.
  • I can use effective birth control if I am sexually active.

You may not be able to join if

  • I am allergic to ferumoxytol or iron sucrose.
  • I have a history of allergy to intravenous iron.
  • I have multiple drug allergies.
  • I have low blood pressure.
  • My hemoglobin level is 7.0 g/dL or lower.
  • My serum ferritin level is above 600 ng/mL.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial

Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemo…
Contacts

Clinical Trial Interest

1-877-374 -4177

CTInterest@covispharma.com

CONTACT