Phase 4
Completed N=293
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
Iron Deficiency Anemia Treatment · Chronic Kidney Disease(CKD)
Source: ClinicalTrials.gov NCT01227616 ↗
Enrolled (actual)
293
Serious AEs
48.5%
Results posted
Jul 2019
Primary outcomePrimary: Hemoglobin Changes — 0.5; 0.4; 0.6; 0.3 g/dL — p=<0.05
◆ Published Evidence
Established
21citations · ~3 / year
Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial
.
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.
Linked Publications (2)
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Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial .
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The Ferumoxytol for Anemia of CKD Trial (FACT)-a randomized controlled trial of repeated doses of ferumoxytol or iron sucrose in patients on hemodialysis: background and rationale.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Changes |
0.5; 0.4; 0.6; 0.3; 0.6; 0.4 | <0.05 sig |
| SECONDARY Changes in Transferrin Saturation (TSAT) |
6.6; 9.5; 8.2; 11.3; 8.5; 9.1 | — |
| SECONDARY Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP |
55; 23; 55; 13; 42; 19 | — |
Eligibility Criteria
Key Inclusion Criteria include:
- 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
Key Exclusion Criteria include:
- 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
Data sourced from ClinicalTrials.gov (NCT01227616) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.