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Sevelamer hydrochloride: an effective phosphate binder in dialyzed children

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Abstract

This pilot study was designed to evaluate the efficacy and acceptability of sevelamer hydrochloride as a phosphate binder in pediatric patients treated with dialysis. A 6-month open-label trial of sevelamer hydrochloride (Renagel) was initiated in 17 patients, aged 11.8±3.7 years, undergoing hemodialysis (n=3) or peritoneal dialysis (n=14). Following a 2-week washout period of the phosphate binders, serum phosphorus increased from 5.2±1.3 mg/dl to 7.5±2.2 mg/dl (P<0.0002). After initiation of therapy with sevelamer hydrochloride, serum phosphorus levels decreased to 6.2±1.2 mg/dl (P<0.01) during the first 8 weeks and final values were 6.3±1.5 mg/dl. Serum calcium concentration decreased during the washout period from 9.4±0.9 mg/dl to 8.9±1.5 mg/dl (P<0.01); values remained unchanged thereafter. The serum calcium-phosphorus ion product decreased during the first 8 weeks and values did not change subsequently. Serum bicarbonate, parathyroid hormone, total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol, and triglyceride levels did not change. The initial prescribed dose of sevelamer hydrochloride was 121±50 mg/kg (4.5±5 g/day) and the final prescribed dose was 163±46 mg/kg (6.7±2.4 g/day). Sevelamer hydrochloride was well tolerated and without adverse effects related to the drug.

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References

  1. Almaden Y, Canalejo A, Hernandez A, Ballesteros E, Garcia-Navarro S, Torres A, Rodriguez M (1996) Direct effect of phosphorus on parathyroid hormone secretion from whole parathyroid glands in vitro. J Bone Miner Res 11:970–976

    CAS  PubMed  Google Scholar 

  2. Slatopolsky E, Finch J, Denda M, Ritter C, Zhong M, Dusso A, MacDonald PN, Brown AJ (1996) Phosphorus restriction prevents parathyroid gland growth. High phosphorus directly stimulates PTH secretion in vitro. J Clin Invest 97:2534–2540

    CAS  PubMed  Google Scholar 

  3. Milliner DS, Zinsmeister AR, Lieberman E, Landing B (1990) Soft tissue calcification in pediatric patients with end-stage renal disease. Kidney Int 38:931–936

    CAS  PubMed  Google Scholar 

  4. Blacher J, Demuth K, Guerin AP, Safar ME, Moatti N, London GM (1998) Influence of biochemical alterations on arterial stiffness in patients with end-stage renal disease. Arterioscler Thromb Vasc Biol 18:535–541

    CAS  PubMed  Google Scholar 

  5. Braun J, Oldendorf M, Moshage W, Heidler R, Zeitler E, Luft FC (1996) Electron beam computed tomography in the evaluation of cardiac calcifications in chronic dialysis patients. Am J Kidney Dis 27:394–401

    CAS  Google Scholar 

  6. Kimura K, Saika Y, Otani H, Fujii R, Mune M, Yukawa S (1999) Factors associated with calcification of the abdominal aorta in hemodialysis patients. Kidney Int [Suppl 71]:S238–S241

  7. Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, Wang Y, Chung J, Emerick A, Greaser L, Elashoff RM, Salusky IB (2000) Coronary artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med 342:1478–1483

    CAS  PubMed  Google Scholar 

  8. Goodman WG (2001) Vascular calcification in chronic renal failure. Lancet 358:1115–1116

    Article  CAS  PubMed  Google Scholar 

  9. Coburn JW, Norris KC, Nebeker HG (1986) Osteomalacia and bone disease arising from aluminum. Semin Nephrol 6:68–89

    CAS  PubMed  Google Scholar 

  10. Salusky IB, Coburn JW, Foley J, Nelson P, Fine RN (1986) Effects of oral calcium carbonate on control of serum phosphorus and changes in plasma aluminum levels after discontinuation of aluminum-containing gels in children receiving dialysis. J Pediatr 108:767–770

    CAS  PubMed  Google Scholar 

  11. Slatopolsky E, Weerts C, Lopez-Hilker S, Norwood K, Zink M, Windus M, Delmez J (1986) Calcium carbonate is an effective phosphate binder in patients with chronic renal failure undergoing dialysis. N Engl J Med 315:157–161

    CAS  PubMed  Google Scholar 

  12. Andreoli SP, Dunson JW, Bergstein JM (1987) Calcium carbonate is an effective phosphorus binder in children with chronic renal failure. Am J Kidney Dis 9:206–210

    CAS  PubMed  Google Scholar 

  13. Salusky IB, Goodman WG (2001) Adynamic renal osteodystrophy: is there a problem? J Am Soc Nephrol 12:1978–1985

    CAS  PubMed  Google Scholar 

  14. Chertow GM, Burke SK, Lazarus JM, Stenzel K, Wombolt D, Goldberg DI, Bonventre JV, Slatopolsky E (1997) Poly[allylamine hydrochloride] (RenaGel): a noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure. Am J Kidney Dis 29:66–71

    CAS  PubMed  Google Scholar 

  15. Goldberg DI, Dillon MA, Slatopolsky EA, Garrett B, Gray JR, Marbury T, Weinberg M, Wombolt D, Burke SK (1998) Effect of RenaGel, a non-absorbed, calcium- and aluminum-free phosphate binder, on serum phosphorus, calcium, and intact parathyroid hormone in end-stage renal disease patients. Nephrol Dial Transplant 13:2303–2310

    CAS  PubMed  Google Scholar 

  16. Wilkes BM, Reiner D, Kern M, Burke S (1998) Simultaneous lowering of serum phosphate and LDL-cholesterol by sevelamer hydrochloride (RenaGel) in dialysis patients. Clin Nephrol 50:381–386

    CAS  PubMed  Google Scholar 

  17. Slatopolsky EA, Burke SK, Dillon MA (1999) RenaGel, a nonabsorbed calcium- and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone. The RenaGel Study Group. Kidney Int 55:299–307

    CAS  PubMed  Google Scholar 

  18. Chertow GM, Dillon M, Burke SK, Steg M, Bleyer AJ, Garrett BN, Domoto DT, Wilkes BM, Wombolt DG, Slatopolsky EA (1999) 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 51:18–26

    CAS  PubMed  Google Scholar 

  19. Chertow GM, Burke SK, Raggi P (2002) Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int 62:245–252

    CAS  Google Scholar 

  20. John MR, Goodman WG, Gao P, Cantor TL, Salusky IB, Jüppner H (1999) A novel immunoradiometric assay detects full-length human PTH but not amino-terminally truncated fragments: implications for PTH measurements in renal failure. J Clin Endocrinol Metab 84:4287–4290

    CAS  PubMed  Google Scholar 

  21. Gao P, Scheibel S, D’Amour P, John MR, Rao DS, Schmidt-Gayk H, Cantor TL (2001) Development of a novel immunoradiometric assay exclusively for biologically active whole parathyroid hormone 1–84: Implications for improvement of accurate assessment of parathyroid function. J Bone Miner Res 16:605–614

    CAS  PubMed  Google Scholar 

  22. Chertow GM, Burke SK, Dillon MA, Slatopolsky E (1999) Long-term effects of sevelamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients. Nephrol Dial Transplant 14:2709–2714

    Google Scholar 

  23. Salusky IB, Foley J, Nelson P, Goodman WG (1991) Aluminum accumulation during treatment with aluminum hydroxide and dialysis in children and young adults with chronic renal disease. N Engl J Med 324:527–531

    CAS  PubMed  Google Scholar 

  24. Block GA, Hulbert-Shearon TE, Levin NW, Port FK (1998) Association of serum phosphorus and calcium x phosphorus product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis 31:607–617

    CAS  PubMed  Google Scholar 

  25. Guerin AP, London GM, Marchais SJ, Metivier F (2000) Arterial stiffening and vascular calcifications in end-stage renal disease. Nephrol Dial Transplant 15:1014–1021

    PubMed  Google Scholar 

  26. Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM (2001) Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension 38:938–942

    CAS  PubMed  Google Scholar 

  27. Kurz P, Monier-Faugere MC, Bognar B, Werner E, Roth P, Vlachojannis J, Malluche HH (1994) Evidence for abnormal calcium homeostasis in patients with adynamic bone disease. Kidney Int 46:855–861

    CAS  PubMed  Google Scholar 

  28. Pierratos A, Ouwendyk M, Francoeur R, Vas S, Raj DSC, Eccestone A, Uldall PR (1998) Nocturnal hemodialysis: three-year experience. J Am Soc Nephrol 9:859–868

    CAS  PubMed  Google Scholar 

  29. Mucsi I, Hercz G, Uldall R, Ouwendyk M, Francoeur R, Pierratos A (1998) Control of serum phosphorus without any phosphate binders in patients treated with nocturnal hemodialysis. Kidney Int 53:1399–1404

    CAS  PubMed  Google Scholar 

  30. Oh J, Wunsch R, Turzer M, Bahner M, Raggi P, Querfeld U, Mehls O, Schaefer F (2002) Advanced coronary and carotid arteriopathy in young adults with childhood-onset chronic renal failure. Circulation 106:100–105

    PubMed  Google Scholar 

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Acknowledgements

This study was supported in part by USPHS grants DK-35423, by GeltTex Pharmaceuticals, and by funds from the Casey Lee Ball Foundation. The results of the study were presented in part at the 2001 American Society of Nephrology Meeting in San Francisco. Dr. Salusky is a consultant for Genzyme Pharmaceutical.

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Correspondence to Isidro B. Salusky.

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Mahdavi, H., Kuizon, B.D., Gales, B. et al. Sevelamer hydrochloride: an effective phosphate binder in dialyzed children. Pediatr Nephrol 18, 1260–1264 (2003). https://doi.org/10.1007/s00467-003-1298-7

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  • DOI: https://doi.org/10.1007/s00467-003-1298-7

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