Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Summary

The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.

Timeline

Start

2010-01

Primary completion

2013-06

Completion

2013-06

Publications

• Background Goldsmith D, Ritz E, Covic A. Vascular calcification: a stiff challenge for the nephrologist: does preventing bone disease cause arterial disease? Kidney Int. 2004 Oct;66(4):1315-33. doi: 10.1111/j.1523-1755.2004.00895.x.
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• Background Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002 Jul;62(1):245-52. doi: 10.1046/j.1523-1755.2002.00434.x.
• Background Fournier A, Said S, Ghazali A, Sechet A, Ezaitouni F, Marie A, Westeel PF, Moriniere P, Boudailliez B. The clinical significance of adynamic bone disease in uremia. Adv Nephrol Necker Hosp. 1997;27:131-66. No abstract available.
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• Background Yang H, Curinga G, Giachelli CM. Elevated extracellular calcium levels induce smooth muscle cell matrix mineralization in vitro. Kidney Int. 2004 Dec;66(6):2293-9. doi: 10.1111/j.1523-1755.2004.66015.x.
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• Background Taal MW, Roe S, Masud T, Green D, Porter C, Cassidy MJ. Total hip bone mass predicts survival in chronic hemodialysis patients. Kidney Int. 2003 Mar;63(3):1116-20. doi: 10.1046/j.1523-1755.2003.00837.x.
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• Background Mansour J, Benyahia M, Harbouche L, Presne C, Moriniere P, Fournier A. Calcimetic AMG 073 at 50 and 100 mg per day. Kidney Int. 2003 Dec;64(6):2324-5. doi: 10.1046/j.1523-1755.2003.341_4.x. No abstract available.
• Background Manns B, Stevens L, Miskulin D, Owen WF Jr, Winkelmayer WC, Tonelli M. A systematic review of sevelamer in ESRD and an analysis of its potential economic impact in Canada and the United States. Kidney Int. 2004 Sep;66(3):1239-47. doi: 10.1111/j.1523-1755.2004.00877.x.
• Background Lacour B, Lucas A, Auchere D, Ruellan N, de Serre Patey NM, Drueke TB. Chronic renal failure is associated with increased tissue deposition of lanthanum after 28-day oral administration. Kidney Int. 2005 Mar;67(3):1062-9. doi: 10.1111/j.1523-1755.2005.00171.x.
• Background Takahashi Y, Tanaka A, Nakamura T, Fukuwatari T, Shibata K, Shimada N, Ebihara I, Koide H. Nicotinamide suppresses hyperphosphatemia in hemodialysis patients. Kidney Int. 2004 Mar;65(3):1099-104. doi: 10.1111/j.1523-1755.2004.00482.x.
• Background Renaud H, Atik A, Herve M, Moriniere P, Hocine C, Belbrik S, Fournier A. Evaluation of vascular calcinosis risk factors in patients on chronic hemodialysis: lack of influence of calcium carbonate. Nephron. 1988;48(1):28-32. doi: 10.1159/000184864.
• Background Wanner C, Krane V, Marz W, Olschewski M, Asmus HG, Kramer W, Kuhn KW, Kutemeyer H, Mann JF, Ruf G, Ritz E; Deutsche Diabetes-Dialyse-Studie (4D) Study Group. Randomized controlled trial on the efficacy and safety of atorvastatin in patients with type 2 diabetes on hemodialysis (4D study): demographic and baseline characteristics. Kidney Blood Press Res. 2004;27(4):259-66. doi: 10.1159/000080241. Epub 2004 Aug 16.
• Background Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31. doi: 10.1016/S0140-6736(04)15786-3.
• Background Moe SM, Chertow GM, Coburn JW, Quarles LD, Goodman WG, Block GA, Drueke TB, Cunningham J, Sherrard DJ, McCary LC, Olson KA, Turner SA, Martin KJ. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005 Feb;67(2):760-71. doi: 10.1111/j.1523-1755.2005.67139.x.
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• Background Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drueke TB, Goodman WG. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25. doi: 10.1056/NEJMoa031633.
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Indications