TerminatedPhase 3

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Stopped: Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-251 study as designed.

United States14 participantsStarted 2011-10-17

Plain-language summary

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Who can participate

Age range6 Months – 17 Years

SexALL

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Inclusion criteria

✓. Males or females 6 months to \<18 years of age
✓. CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
✓. Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level \<100 nanograms/milliliter (ng/mL)
✓. Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

Exclusion criteria

✕. History of allergy to either oral or IV iron
✕. Hemoglobin level ≤7.0 g/dL
✕. Serum ferritin level \>600 ng/mL
✕. Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test

What they're measuring

Mean Change In Hemoglobin From Baseline To Week 5

Timeframe: Baseline, Week 5

Trial details

NCT IDNCT01155375

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06-24

Results submitted2017-08-10

View on ClinicalTrials.gov More Iron Deficiency Anemia trials