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This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.
This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferumoxytol or placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16088081 | 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. | |
| 18824288 | Result | Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27. |
| Label | URL |
|---|---|
| National Kidney Foundation | View source |
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| Phoenix |
| Arizona |
| 85012 |
| United States |
| Mountain View | California | 94041 | United States |
| New Haven | Connecticut | 06511 | United States |
| Washington D.C. | District of Columbia | 20854 | United States |
| Ocala | Florida | 34471 | United States |
| Tampa | Florida | 33614 | United States |
| Atlanta | Georgia | 30308 | United States |
| Augusta | Georgia | 30901 | United States |
| Newnan | Georgia | 30265 | United States |
| Peoria | Illinois | 61603 | United States |
| Shreveport | Louisiana | 71101 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Bethesda | Maryland | 20814 | United States |
| Boston | Massachusetts | 02135 | United States |
| Detroit | Michigan | 48236 | United States |
| St Louis | Missouri | 63136 | United States |
| Broken Bow | Nebraska | 68822 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Flushing | New York | 11355 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| Orchard Park | New York | 14127 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Columbus | Ohio | 43210 | United States |
| Portland | Oregon | 97213 | United States |
| Erie | Pennsylvania | 16176 | United States |
| Lancaster | Pennsylvania | 17604 | United States |
| Greenville | South Carolina | 29605 | United States |
| Sumter | South Carolina | 29150 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Knoxville | Tennessee | 37923 | United States |
| Austin | Texas | 78758 | United States |
| Houston | Texas | 77074 | United States |
| San Antonio | Texas | 78212 | United States |
| Alexandria | Virginia | 22304 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Norfolk | Virginia | 23507 | United States |
| Bluefield | West Virginia | 24701 | United States |
| Appleton | Wisconsin | 54911 | United States |
| 37651553 | Derived | Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
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