drugset / Trial / NCT00233597
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.
Timeline
- Start
- 2004-08
- Primary completion
- —
- Completion
- 2007-03
Outcome
Met primary endpoint
paper Ferumoxytol resulted in a mean increase in hemoglobin of 1.02 +/- 1.13 g/dl at day 35 compared with 0.46 +/- 1.06 g/dl PMID 19176796 ↗
paper (P = 0.0002). PMID 19176796 ↗
Publications
- Background Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
- Results Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferumoxytol | Diagnostic / imaging agent | 510 mg | Intravenous |
| Subject | ferumoxytol or oral iron | Unknown | 200 mg | Oral |