American Journal of Kidney Diseases
Volume 55, Issue 2 , Pages 307-315 , February 2010

A Randomized, Parallel, Open-Label Study to Compare Once-Daily Sevelamer Carbonate Powder Dosing With Thrice-Daily Sevelamer Hydrochloride Tablet Dosing in CKD Patients on Hemodialysis

  • Steven Fishbane, MD

      Affiliations

    • Winthrop University Hospital, Mineola, NY
    • Corresponding Author InformationAddress correspondence to Steven Fishbane, MD, Winthrop University Hospital, Division of Nephrology and Hypertension, 200 Old Country Rd, Ste 135, Mineola, NY 11501
    • ,
  • James Delmez, MD

      Affiliations

    • Washington University School of Medicine, St. Louis, MO
    • ,
  • Wadi N. Suki, MD

      Affiliations

    • The Kidney Institute and Baylor College of Medicine, Houston, TX
    • ,
  • Srinivas K. Hariachar, MD

      Affiliations

    • Outcomes Research International Inc, Hudson, FL
    • ,
  • Jeremy Heaton, MD

      Affiliations

    • Genzyme Corp, Cambridge, MA
    • ,
  • Scott Chasan-Taber, PhD

      Affiliations

    • Genzyme Corp, Cambridge, MA
    • ,
  • Melissa A. Plone, MA

      Affiliations

    • Genzyme Corp, Cambridge, MA
    • ,
  • Sharon Moe, MD

      Affiliations

    • Indiana University and Roudebush VAMC, Indianapolis, IN

Received 5 May 2009 ,Accepted 15 October 2009.

References 

  1. Karamanidou C, Clatworthy J, Weinman J, Horne R. A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease. BMC Nephrol. 2008;9:2
  2. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;3:1296–1310
  3. Eisen SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. The effect of prescribed daily dose frequency on patient medication compliance. Arch Intern Med. 1990;150(9):1881–1884
  4. Strachan I, Greener M. Medication-related swallowing difficulties may be more common than we realize. Pharm Pract. 2005;Nov/Dec:411-414
  5. Anderson O, Zweidorff O, Hjelde T, Rodland E. Problems when swallowing tablets (A questionnaire study from general practice). Tidsskr Nor Laegeforen. 1995;115(8):947–949
  6. Fischer D, Cline K, Plone MA, Dillon M, Burke SK, Blair AT. Results of a randomized crossover study comparing once-daily and thrice-daily sevelamer dosing. Am J Kidney Dis. 2006;48(3):437–444
  7. Chertow GM, Burke SK, Lazarus JM, et al. Poly[allylamine hydrochloride] (RenaGel): a noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure. Am J Kidney Dis. 1997;29(1):66–71
  8. Goldberg DI, Dillon MA, Slatopolsky EA, et al. Effect of RenaGel, a non-absorbed, calcium- and aluminium-free phosphate binder, on serum phosphorus, calcium, and intact parathyroid hormone in end-stage renal disease patients. Nephrol Dial Transplant. 1998;13(9):2303–2310
  9. Bleyer AJ, Burke SK, Dillon M, et al. A comparison of the calcium-free phosphate binder sevelamer hydrochloride with calcium acetate in the treatment of hyperphosphatemia in hemodialysis patients. Am J Kidney Dis. 1999;33(4):694–701
  10. Chertow GM, Burke SK, Dillon MA, Slatopolsky E. Long-term effects of sevelamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients. Nephrol Dial Transplant. 1999;14(12):2907–2914
  11. Chertow GM, Dillon M, Burke SK, et al. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium (Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients). Clin Nephrol. 1999;51(1):18–26
  12. Slatopolsky EA, Burke SK, Dillon MAfor the Renagel Study Group. RenaGel, a nonabsorbed calcium- and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone. Kidney Int. 1999;55(1):299–307
  13. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62(1):245–252
  14. Evenepoel P, Selgas R, Caputo F, et al. Efficacy and safety of sevelamer hydrochloride and calcium acetate in patients on peritoneal dialysis. Nephrol Dial Transplant. 2009;24(1):278–285
  15. Young EW, Akiba T, Albert JM, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004;44(5 suppl 2):S34–S38
  16. Young EW, Albert JM, Satayathum S, et al. Predictors and consequences of altered mineral metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2005;67(3):1179–1187
  17. Fan S, Ross C, Mitra S, et al. A randomized, cross-over design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on hemodialysis. Nephrol Dial Transplant. 2009;24(12):3794–3799

 Originally published online as doi:10.1053/j.ajkd.2009.10.051 on December 31, 2009.

 Trial registration: www.clinicaltrials.gov; study number: NCT00324376.

PII: S0272-6386(09)01450-4

doi: 10.1053/j.ajkd.2009.10.051

American Journal of Kidney Diseases
Volume 55, Issue 2 , Pages 307-315 , February 2010

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