TerminatedPhase 3

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

Stopped: Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-252 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
✓. Nondialysis dependent CKD, including kidney transplant recipients
✓. Has iron deficiency anemia defined as: a) hemoglobin level \<11.0 grams (g)/deciliter (dL) and b) transferrin saturation level \<20%
✓. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study

Exclusion criteria

✕. History of allergy to either oral or IV iron
✕. Allergy to two or more classes of drugs
✕. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
✕. Hemoglobin level ≤7.0 g/dL
✕. Serum ferritin level \>600 nanograms/milliliter

What they're measuring

Mean Change In Hemoglobin From Baseline To Week 5

Timeframe: Baseline, Week 5

Trial details

NCT IDNCT01155388

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06-24

Results submitted2017-08-10

View on ClinicalTrials.gov More Iron Deficiency Anemia trials