CompletedPhase 4

Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

United States296 participantsStarted 2013-08

Plain-language summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Males and females ≥18 years of age
✓. Diagnosis of CKD
✓. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
✓. Female subjects 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
✕. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
✕. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study

What they're measuring

Hemoglobin Changes

Timeframe: Up to 6 treatment periods (5 weeks per treatment period)

Trial details

NCT IDNCT01227616

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2019-05-23

View on ClinicalTrials.gov More Iron Deficiency Anemia Treatment trials