Pharmacokinetic study of ferumoxytol: A new iron replacement therapy in normal subjects and hemodialysis patients

American Journal of Nephrology

Volumn 25, Issue 4, 2005, Pages 400-410

  Landry, Robert ^a,d   Jacobs, Paula M ^b   Davis, Robert ^a   Shenouda, Magdy ^c   Bolton, W Kline ^a  

^a UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^b Advanced Magnetics Inc   (United States)

^c JERSEY SHORE UNIVERSITY MEDICAL CENTER   (United States)

^d Diabet Ctr of the Baton Rouge G   (United States)

Author keywords

Chronic kidney disease; Ferumoxytol; Intravenous iron; Iron pharmacokinetics; Renal anemia

Indexed keywords

FERRITIN; FERUMOXYTOL; IRON; IRON OXIDE; PLACEBO; TRANSFERRIN; UNCLASSIFIED DRUG;

ADULT; AGED; ANAPHYLAXIS; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HUMAN; HYPOTENSION; INJECTION; IRON BLOOD LEVEL; IRON THERAPY; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PLASMA HALF LIFE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUBSTITUTION THERAPY; TASTE DISORDER;

ADULT; AGED; ANEMIA; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ERYTHROPOIETIN; FEMALE; HEMATINICS; HUMANS; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; RENAL DIALYSIS; TREATMENT OUTCOME;

EID: 23844526815     PISSN: 02508095     EISSN: None     Source Type: Journal    
DOI: 10.1159/000087212     Document Type: Article

References (46)

1. Excerpts from the US Renal Data System's 2001 Annual Data Report: Atlas of end-stage renal disease in the United States. Am J Kidney Dis 2001;38:S135-S146.
2. National Kidney Foundation: K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease. Am J Kidney Dis 2001;37: S182-S238.
3. Silverberg DS, Blum M, Agbaria Z, Schwartz D, Zubkov A, Yachnin T, Iaina A: Intravenous iron for the treatment of predialysis anemia. Kidney Int 1999;69:S79-S85.
4. Wizemann V, Kaufmann J, Kramer W: Effect of erythropoietin on ischemia tolerance in anemic hemodialysis patients with confirmed coronary artery disease. Nephron 1992;62:161-165.
5. Zehnder C, Zuber M, Sulzer M, Meyer B, Straumann E, Jenzer HR, Blumberg A: Influence of long-term amelioration of anemia and blood pressure control on left ventricular hypertrophy in hemodialyzed patients. Nephron 1992;61:21-25.
6. Macdougall IC, Lewis NP, Saunders MJ, Cochlin DL, Davies ME, Hutton RD, Fox KA, Coles GA, Williams JD: Long-term cardiorespiratory effects of amelioration of renal anaemia by erythropoietin. Lancet 1990;335:489-493.
7. Mann JFE: Hypertension and cardiovascular effects: long-term safety and potential long-term benefits of rHuEPO. Nephrol Dial Transplant 1995;10:80-84.
8. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW: Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med 1987; 316:73-78.
9. Fishbane S, Maesaka JK: Iron management in end-stage renal disease. Am J Kidney Dis 1997;29:319-333.
10. Lindsay RM, Burton JA, Edward N, Dargie HJ, Prentice CR, Kennedy AC: Dialyzer blood loss. Clin Nephrol 1973;1:29-34.
11. Muller-Wiefel DE, Sinn H, Gilli G, Scharer K: Hemolysis and blood loss in children with chronic renal failure. Clin Nephrol 1977;8:481-486.
12. Van Wyck DB: Iron deficiency in patients with dialysis-associated anemia during erythropoietin replacement therapy: strategies for assessment and management. Semin Nephrol 1989; 9:21-24.
13. Horl WH, Dreyling K, Steinhauer HB, Engelhardt R, Schollmeyer P: Iron status of dialysis patients under rhuEPO therapy. Contrib Nephrol. Basel, Karger, 1990, vol 87, pp 78-86.
14. Van Wyck DB, Stivelman JC, Ruiz J, Kirlin LF, Katz MA, Ogden DA: Iron status in patients receiving erythropoietin for dialysis-associated anemia. Kidney Int 1989;35:712-716.
15. Wingard RL, Parker RA, Ismail N, Hakim RM: Efficacy of oral iron therapy in patients receiving recombinant human erythropoietin. Am J Kidney Dis 1995;25:433-439.
16. Macdougall IC, Tucker B, Thompson J, Tomson CR, Baker LR, Raine AE: A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int 1996;50:1694-1699.
17. Silverberg DS, Iaina A, Peer G, Kaplan E, Levi BA, Frank N, Steinbruch S, Blum M: Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis 1996;27:234-238.
18. Burns DL, Pomposelli JJ: Toxicity of parenteral iron dextran therapy. Kidney Int 1999;69:S119-S124.
19. Ferrlecit® product package insert, 2001. Watson Pharma, Inc.
20. Venofer® product package insert, 2000.
21. Vychytil A, Haag-Weber M: Iron status and iron supplementation in peritoneal dialysis patients. Kidney Int 1999;69:S71-S78.
22. Horl WH: Should we still use iron dextran in hemodialysis patients? Am J Kidney Dis 2001; 37:859-861.
23. Fishbane S, Ungureanu VD, Maesaka JK, Kaupke CJ, Lim V, Wish J: The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis 1996;28:529-534.
24. Charytan C, Levin N, Al Saloum M, Hafeez T, Gagnon S, Van Wyck DB: Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis 2001;37:300-307.
25. McLachlan SJ, Morris MR, Lucas MA, Fisco RA, Eakins MN, Fowler DR, Scheetz RB, Olukotun AY: Phase I clinical evaluation of a new iron oxide MR contrast agent. J Magn Reson Imaging 2002;4:301-307.
26. National Kidney Foundation: K/DOQI Clinical Practice Guidelines for chronic kidney disease: evaluation, classification and stratification. Am J Kidney Dis 2002;39:81-8266.
27. Hamstra RD, Block MH, Schocket AL: Intravenous iron dextran in clinical medicine. JAMA 1980;243:1726-1731.
28. Auerbach M, Witt D, Toler W, Fierstein M, Lerner RG, Ballard H: Clinical use of the total dose intravenous infusion of iron dextran. J Lab Clin Med 1988;111:566-570.
29. Hedin H, Ljungstrom KG: Prevention of dextran anaphylaxis - Ten years' experience with hapten dextran. Int Arch Allergy Immunol 1997;113:358-359.
30. Faich G, Strobos J: Sodium ferric gluconate complex in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis 1999;33:464-470.
31. Pascual J, Teruel JL, Liano F, Sureda A, Ortuno J: Intravenous Fe-gluconate-Na for iron-deficient patients on hemodialysis. Nephron 1992;60:121.
32. Nissenson AR, Lindsay RM, Swan S, Seligman P, Strobos J: Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis 1999;33:471-482.
33. Michael B, Coyne DW, Folkert VW, Dahl NV, Warnock DG: Sodium ferric gluconate complex in haemodialysis patients: a prospective evaluation of long-term safety. Nephrol Dial Transplant 2004;19:1576-1580.
34. Van Wyck DB, Cavallo G, Spinowitz BS, Adhikarla R, Gagnon S, Charytan C, Levin N: Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis 2000;36:88-97.
35. Chandler G, Harchowal J, Macdougall IC: Intravenous iron sucrose: establishing a safe dose. Am J Kidney Dis 2001;38:988-991.
36. Aronoff GR, Bennett WM, Blumenthal S, Charytan C, Pennell JP, Reed J, Rothstein M, Strom J, Wolfe A, Van Wyck D, Yee J: Iron sucrose in hemodialysis patients: safety of replacement and maintenance regimens. Kidney Int 2004;66:1193-1198.
37. Van Wyck DB: Labile iron: manifestations and clinical implications. J Am Soc Nephrol 2004; 15(suppl 2):S107-S111.
38. Zager RA, Johnson AC, Hanson SY: Parenteral iron nephrotoxicity: potential mechanisms and consequences. Kidney Int 2004;66:144-156.
39. Alam MG, Krause MW, Shah SV: Parenteral iron therapy: beyond anaphylaxis. Kidney Int 2004;66:457-458.
40. Danielson BG: Structure, chemistry, and pharmacokinetics of intravenous iron agents. J Am Soc Nephrol 2004;15(suppl 2):S93-S98.
41. Lewis J, Jacobs P, Frigio T: Comparison of free iron in ferumoxytol with other iron therapeutics. J Am Soc Nephrol 2003;14:771A.
42. Jacobs P, Lewis JM, Frigio TB: Bleomycin detectable iron and percent transferrin saturation in the serum of patients receiving either ferumoxytol, iron gluconate or iron sucrose. J Am Soc Nephrol 2004;15:546A.
43. Physicians' Desk Reference, ed 58. Motvale/ NJ, Thompson, 2004.
44. St Peter WL, Lambrecht LJ, Macres M: Randomized cross-over study of adverse reactions and cost implications of intravenous push compared with infusion of iron dextran in hemodialysis patients. Am J Kidney Dis 1996;28:523-528.
45. Dahdah K, Patrie JT, Bolton WK: Intravenous iron dextran treatment in predialysis patients with chronic renal failure. Am J Kidney Dis 2000;36:775-782.
46. Sargent JA, Kingston WW: Analyzing the true cost of delivering medications. Am J Kidney Dis 2005;45:917-925.