TerminatedPhase 3

A Trial of Ferumoxytol for the Episodic 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-253 study as designed.

United States8 participantsStarted 2011-12-27

Plain-language summary

Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

Who can participate

Age range6 Months – 17 Years

SexALL

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Inclusion criteria

✓. Participants who had completed participation in the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies within 4 weeks of screening
✓. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
✓. Participant and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study

Exclusion criteria

✕. Experienced a serious adverse event related to IV iron therapy in the combined AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies
✕. Hemoglobin level ≤7 g/dL

What they're measuring

Mean Change In Hemoglobin From Baseline To Week 5

Timeframe: Baseline, Week 5

Trial details

NCT IDNCT01264679

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04-24

Results submitted2017-08-10

View on ClinicalTrials.gov More Iron Deficiency Anemia trials