Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens

Kidney International

Volumn 66, Issue 3, 2004, Pages 1193-1198

  Aronoff, George R ^b   Bennett, William M ^b   Blumenthal, Samuel ^b   Charytan, Chaim ^b   Pennell, J Phillip ^b   Reed, John ^b   Rothstein, Marcos ^b   Strom, James ^b   Wolfe, Anthony ^b   Van Wyck, David ^a   Yee, Jerry ^b  

^a Kidney Health Institute LLC   (United States)

^b NONE

Author keywords

Anemia; Hemodialysis; Iron deficiency; Iron sucrose; Safety

Indexed keywords

AMINOTRANSFERASE; FERRIC HYDROXIDE SUCROSE;

ADULT; AGED; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DERMATITIS; DIARRHEA; DIZZINESS; DRUG DOSE REGIMEN; DRUG SAFETY; FEMALE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HUMAN; HYPOTENSION; IRON BLOOD LEVEL; IRON DEFICIENCY; IRON STORAGE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SUBSTITUTION THERAPY; TASTE DISORDER; VOMITING; XEROSTOMIA;

EID: 4344560350     PISSN: 00852538     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1523-1755.2004.00872.x     Document Type: Article

References (19)

1. GUIDELINE FOR INDUSTRY CLINICAL SAFETY DATA MANAGEMENT: Definitions and Standards for Expedited Reporting, ICH-E2A, Rockville (MD), Center for Drug Evaluation and Research, 1995
2. US RENAL DATA SYSTEM: USRDS 1999 Annual Data Report 92. Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 1999
3. NKF-K/DOQI: Clinical practice guidelines for anemia of chronic kidney disease: Update 2000. Am J Kidney Dis 37:S182-S238, 2001
4. US RENAL DATA SYSTEM: USRDS 2002 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2002
5. BAILIE GR, JOHNSON CA, MASON NA: Parenteral iron use in the management of anemia in end-stage renal disease patients. Am J Kidney Dis 35:1-12, 2000
6. CHARYTAN C, LEVIN N, AL SALOUM M, et al: Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis 37:300-307, 2001
7. COYNE DW, ADKINSON NF, NISSENSON AR, et al: Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney Int 63:217-224, 2003
8. FAICH G, STROBOS J: Sodium ferric gluconate complex in sucrose: Safer intravenous iron therapy than iron dextran. Am J Kidney Dis 33:464-470, 1999
9. FISHBANE S: Review of issues relating to iron and infection. Am J Kidney Dis 34:S47-S52, 1999
10. FISHBANE S, UNGUREANU VD, MAESAKA JK, et al: The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis 28:529-534, 1996
11. FLETES R, LAZARUS JM, GAGE J, et al: Suspected iron dextran-related adverse drug events in hemodialysis patients. Am J Kidney Dis 37:743-749, 2001
12. FOLKERT VW, MICHAEL B, AGARWAL R, et al: Chronic use of sodium ferric gluconate complex in hemodialysis patients: Safety of higher-dose (> or = 250 mg) administration. Am J Kidney Dis 41:651-657, 2003
13. FURULAND H, LINDE T, AHLMEN J, et al: A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients. Nephrol Dial Transplant 18:353-361, 2003
14. HAMSTRA RD, BLOCK MH, SCHOCK AL, et al: Intravenous iron dextran in clinical medicine. JAMA 243:1726-1731, 1980
15. HOEN B, PAUL-DAUPHIN A, HESTIN D, et al: EPIBACDIAL: A multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients. J Am Soc Nephrol 9:869-876, 1998
16. MICHAEL B, COYNE DW, FISHBANE S, et al: Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney Int 61:1830-1839, 2002
17. NISSENSON AR, LINDSAY RM, SWAN S, et al: Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis 33:471-482, 1999
18. TAUPITZ M, SCHMITZ S, HAMM B: Superparamagnetic iron oxide particles: Current state and future development. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 175:752-765, 2003
19. VAN WYCK DB, CAVALLO G, SPINOWITZ BS, et al: Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis 36:88-97, 2000