Sevelamer carbonate lowers serum phosphorus effectively in haemodialysis patients: A randomized, double-blind, placebo-controlled, dose-titration study

Nephrology Dialysis Transplantation

Volumn 29, Issue 1, 2014, Pages 152-160

  Chen, Nan ^a   Wu, Xiongfei ^b   Ding, Xiaoqiang ^c   Mei, Changlin ^d   Fu, Ping ^e   Jiang, Gengru ^f   Li, Xuemei ^g   Chen, Jianghua ^h   Liu, Bicheng ⁱ   La, Yan ^j   Hou, Fanfan ^k   Ni, Zhaohui ^f   Fu, Junzhou ^l   Xing, Changying ^m   Yu, Xuequing ⁿ   Huang, Chaoxing ^o   Zuo, Li ^p   Wang, Li ^q   Hunter, John ^r   Dillon, Maureen ^r   Plone, Melissa ^r   Neylan, John ^r   more..

^a SHANGHAI SECOND MEDICAL UNIVERSITY   (China)

^b SOUTHWEST HOSPITAL   (China)

^c ZHONGSHAN HOSPITAL OF FUDAN UNIVERSITY   (China)

^d SECOND MILITARY MEDICAL UNIVERSITY   (China)

^e SICHUAN UNIVERSITY   (China)

^f SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE   (China)

^g PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^h ZHEJIANG UNIVERSITY   (China)

ⁱ SOUTHEAST UNIVERSITY   (China)

^j QINGDAO MUNICIPAL HOSPITAL   (China)

^k FIRST MILITARY MEDICAL UNIVERSITY   (China)

^l GUANGZHOU FIRST PEOPLE'S HOSPITAL   (China)

^m THE FIRST AFFILIATED HOSPITAL OF NANJING MEDICAL UNIVERSITY   (China)

ⁿ SUN YAT SEN UNIVERSITY   (China)

^o THE FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY   (China)

^p PEKING UNIVERSITY FIRST HOSPITAL   (China)

^q SICHUAN PROVINCIAL PEOPLE'S HOSPITAL   (China)

^r GENZYME CORPORATION   (United States)

more..

Author keywords

clinical study; haemodialysis; hyperphosphataemia; placebo; sevelamer carbonate

Indexed keywords

BICARBONATE; CHOLESTEROL ESTER; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NON HIGH DENSITY LIPOPROTEIN CHOLESTEROL; PHOSPHATE; PLACEBO; SEVELAMER CARBONATE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CHINESE; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL DISEASE; HEMODIALYSIS; HUMAN; HYPERPHOSPHATEMIA; MAJOR CLINICAL STUDY; MALE; PATIENT COMPLIANCE; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

CLINICAL STUDY; HAEMODIALYSIS; HYPERPHOSPHATAEMIA; PLACEBO; SEVELAMER CARBONATE;

ADULT; AGED; CHELATING AGENTS; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERPHOSPHATEMIA; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; PHOSPHATES; PHOSPHORUS; POLYAMINES; RENAL DIALYSIS; YOUNG ADULT;

EID: 84892774231     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gft232     Document Type: Article

References (33)

1. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42(Suppl 3): S1-S201
2. Block GA, Hulbert-Shearon TE, Levin NW et al. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis 1998; 31: 607-617
3. Block GA, Klassen PS, Lazarus JM et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004; 15: 2208-2218
4. Ganesh SK, Stack AG, Levin NW et al. Association of elevated serum PO(4), Ca x PO(4) product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients. J Am Soc Nephrol 2001; 12: 2131-2138
5. Kestenbaum B, Belozeroff V. Mineral metabolism disturbances in patients with chronic kidney disease. Eur J Clin Invest 2007; 37: 607-622
6. Lowrie EG, Lew NL. Death risk in hemodialysis patients: the predictive value of commonly measured variables and an evaluation of death rate differences between facilities. Am J Kidney Dis 1990; 15: 458-482
7. Slinin Y, Foley RN, Collins AJ. Calcium, phosphorus, parathyroid hormone, and cardiovascular disease in hemodialysis patients: the USRDS waves 1, 3, and 4 study. J Am Soc Nephrol 2005; 16: 1788-1793
8. 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: 1179-1187
9. Isakova T, Gutiérrez OM, Chang Y et al. Phosphorus binders and survival on hemodialysis. J Am Soc Nephrol 2009; 20: 388-396
10. Chertow GM, Burke SK, Lazarus JM et al. Poly[allylamine hydro-chloride] (RenaGel): a noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure. Am J Kidney Dis 1997; 29: 66-71
11. Finn WF, Joy MS, Hladik G. Lanthanum Study Group. Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialy-sis. Clin Nephrol 2004; 62: 193-201
12. Shigematsu T. Lanthanum Carbonate Research Group. Lanthanum carbonate effectively controls serum phosphate without affecting serum calcium levels in patients undergoing hemodialysis. Ther Apher Dial 2008; 12: 55-61
13. 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: 2303-2310
14. Chertow GM, Burke SK, Dillon MA et al. Long-term effects of se-velamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients. Nephrol Dial Transplant 1999; 14: 2907-2914
15. Chertow GM, Dillon M, Burke SK et al. A randomized trial of se-velamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hy-perparathyroidism in hemodialysis patients. Clin Nephrol 1999; 51: 18-26
16. Slatopolsky EA, Burke SK, Dillon MA. RenaGel, a nonabsorbed calcium-and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone. The RenaGel Study Group. Kidney Int 1999; 55: 299-307
17. 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 hemo-dialysis patients. Am J Kidney Dis 1999; 33: 694-701
18. Evenepoel P, Selgas R, Caputo F et al. Efficacy and safety of seve-lamer hydrochloride and calcium acetate in patients on peritoneal dialysis. Nephrol Dial Transplant 2009; 24: 278-285
19. Chertow GM, Burke SK, Raggi P. The Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int 2002; 62: 245-252
20. Delmez J, Block G, Robertson J et al. A randomized, double-blind, crossover design study of sevelamer hydrochloride and se-velamer carbonate in patients on hemodialysis. Clin Nephrol 2007; 68: 386-391
21. Fan S, Ross C, Mitra S et al. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochlo-ride tablets in chronic kidney disease patients on haemodialysis. Nephrol Dial Transplant 2009; 24: 3794-3799
22. Moustafa M, Lehrner L, Al-Saghir F et al. A randomized, double-blind, placebo-controlled, dose-ranging study using Genz-644470 and sevelamer carbonate in hyperphosphatemic chronic kidney disease patients on hemodialysis. Nephrol Dial Transplant Plus 2010; 3(Suppl 3): iii236-iii237
23. Ketteler M, Rix M, Fan S et al. Efficacy and tolerability of sevela-mer carbonate in hyperphosphatemic patients who have chronic kidney disease and are not on dialysis. Clin J Am Soc Nephrol 2008; 3: 1125-1130
24. Braunlin W, Zhorov E, Guo A et al. Bile acid binding to sevela-mer HCl. Kidney Int 2002; 62: 611-619
25. Wheeler DC. Should hyperlipidaemia in dialysis patients be treated? Nephrol Dial Transplant 1997; 12: 19-21
26. Kjekshus J, Pedersen TR. Reducing the risk of coronary events: evidence from the Scandinavian Simvastatin Survival Study (4S). Am J Cardiol 1995; 76: 64C-68C
27. Hebert PR, Gaziano JM, Chan KS et al. Cholesterol lowering with statin drugs, risk of stroke, and total mortality. An overview of randomized trials. JAMA 1997; 278: 313-321
28. Fellström BC, Jardine AG, Schmieder RE et al. AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009; 360: 1395-1407
29. Wanner C, Krane V, März W et al. German Diabetes and Dialysis Study Investigators. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005; 353: 238-248
30. Sharp Collaborative Group. Study of Heart and Renal Protection (SHARP): randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9, 438 patients with chronic kidney disease. Am Heart J 2010; 160: 785-794.e10
31. Kraut JA. The role of metabolic acidosis in the pathogenesis of renal osteodystrophy. Adv Ren Replace Ther 1995; 2: 40-51
32. Kalantar-Zadeh K, Mehrotra R, Fouque D et al. Kopple JD. Metabolic acidosis and malnutrition-inflammation complex syndrome in chronic renal failure. Semin Dial 2004; 17: 455-465
33. Bommer J, Locatelli F, Satayathum S et al. Association of predia-lysis serum bicarbonate levels with risk of mortality and hospital-ization in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004; 44: 661-671