Renagel^® (sevelamer hydrochloride)

Bibliographical Information:

Drug Name	Generic Name	Studied Indications or Disease	Approved U.S. Drug Label
Renagel®	sevelamer hydrochloride	chronic kidney disease	Prescribing Info

Protocol GTC-02-101

No associated publications.

Protocol GTC-10-201

Chertow GM, Burke SK, Lazarus JM, Stenzel KH, Wombolt D, Goldberg D, Bonventre JV, Slatopolsky E. 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.

Protocol GTC-10-202

Goldberg DI, Dillon MA, Slatopolsky EA, Garrett B, Gray JR, Marbury T, Weinberg M, Wombolt D, Burke SK. 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.

Protocol GTC-10-801

Plone M, Petersen J, Rosenbaum D, Burke SK. Sevelamer, a phosphate-binding polymer, is a non-absorbed compound. Clinical Pharmacokinetics 2002;41(7):517-523.

Burke SK, Slatopolsky EA, Goldberg DI. RenaGel®, a novel calcium- and aluminum-free phosphate binder, inhibits phosphate absorption in normal volunteers. Nephrol Dial Transplant 1999; (12):1640-1644.

Protocol GTC-36-203

Chertow GM, Dillon M, Burke SK, Steg M, Bleyer AJ, Garrett BN, Domoto DT, Wilkes BM, Wombolt DG, Slatopolsky E. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Clin Nephrol 1999; 51:18-26.

Protocol GTC-36-301

Bleyer AJ, Burke SK, Dillon M, Garrett B, Kant KS, Lynch D, Rahman SN, Schoenfeld P, Teitelbaum I, Zeig S, Slatopolsky E. 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;33:694-701.

Protocol GTC-36-302

Slatopolsky E, Burke SK, Dillon M, and the Renagel^® Study Group. RenaGel^®, a nonabsorbed calcium- and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone. Kidney International 1999; 55:299-307.

Wilkes BM, Reiner D, Kern M, Burke S. Simultaneous lowering of serum phosphate and LDL-cholesterol by sevelamer hydrochloride (RenaGel) in dialysis patients. Clin Nephrol 1998;50-6:381-386.

Protocol GTC-45-204

No associated publications.

Protocol GTC-45-206

Mahdavi H, Kuizon BD, Gales B, Wang H-J, Elashoff RM, Salusky IB. Sevelamer hydrochloride: an effective phosphate binder in dialyzed children. Pediatr Nephrol 2003;18:1260-4.

Protocol GTC-68-208

No associated publications.

Protocol GTC-68-209

No associated publications.

Protocol GTC-45-803

Chertow GM, Dillon M, Burke SK, Steg M, Bleyer AJ, Garrett BN, Domoto DT, Wilkes BM, Wombolt DG, Slatopolsky E. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Clin Nephrol 1999; 51:18-26.

Burke SK, Amin NS, Incerti C, Plone MA, Lee JW. Sevelamer hydrochloride (Renagel®), a phosphate-binding polymer, does not alter the pharmacokinetic of two commonly used antihypertensives in healthy volunteers. Journal of Clinical Pharmacology 2001; 41:199-205.

Protocol GTC-45-804

Burke SK, Amin NS, Incerti C, Plone MA, Lee JW. Sevelamer hydrochloride (Renagel®), a phosphate-binding polymer, does not alter the pharmacokinetic of two commonly used antihypertensives in healthy volunteers. Journal of Clinical Pharmacology 2001; 41:199-205.

Protocol GTC-45-807

Kays MB, Overholser BR, Mueller BA, Moe SM, Sowinski KM. Effects of sevelamer hydrochloride and calcium acetate on the oral bioavailability of ciprofloxacin. Am J Kidney Disease 2003; 42:1253-9.

Kays MB, Overholser BR, Mueller BA, Moe SM, Sowinski KM. Effect of sevelamer and calcium acetate on the relative oral bioavailability of ciprofloxacin. Journal of the American Society of Nephrology 2002:13;F-P0961.

Protocol GTC-45-808

Pruchnicki MC, Coyle JD, Hoshaw-Woodard S, Bay WH. Effect of phosphate binders on supplemental iron absorption in healthy subjects. J Clin Pharmacol 2002; 42:1171-1176.

Pruchnicki MC, Coyle JD, Hoshaw-Woodard S, Bay WH. Effect of phosphate binders on supplemental iron absorption in healthy subjects. Journal of American Society of Nephrology 2001; 12:407A.

Protocol GTC-45-901

No associated publications.

Protocol GTC-49-301

Raggi P, Boulay A, Chasan-Taber S, Amin N, Dillon M, Burke SK, Chertow GM. Cardiac calcification in adult hemodialysis patients: a link between end-stage renal disease and cardiovascular disease. Journal of the Am Col Cardio 2002;39:695-701.

Chertow GM, Burke SK, Raggi P, for the Treat to Goal Working Group. Sevelamer attenuates the progression of cardiovascular calcification in hemodialysis patients. Kidney International 2002; 62:245–252.

Chertow GM, Raggi P, McCarthy JT, Schulman G, Silberzweig J, Kuhlik A, Goodman WG, Boulay A, Burke SK, Toto RD. The effects of sevelamer and calcium acetate on proxies of atherosclerotic and arteriosclerotic vascular disease in hemodialysis patients. Am J Nephrol 2003;23:307-14.

Chertow GM. Slowing the progression of vascular calcification in hemodialysis. J Am Soc Nephrol 2003; 14: S310-S314.

Chertow GM, Raggi P, Chasan-Taber S, Bommer J, Holzer H, Burke SK. Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant 2004;19:1489-96.

Raggi P, Bommer J, Chertow GM. Valvular calcification in hemodialysis patients randomized to calcium-based phosphorus binders or sevelamer. J Heart Valve Dis 2004;13:134-41.

Braun J, Asmus HG, Holzer H, Brunkhorst R, Krause R, Schulz W, Neumayer HH, Raggi P, Bommer J. Long-term comparison of a calcium-free phosphate binder and calcium carbonate: phosphorus metabolism and cardiovascular calcification. Clin Nephrol 2004; 62:104-115.

Garg JP, Chasan-Taber S, Blair A, Plone M, Bommer J, Raggi P, Chertow GM. Effects of sevelamer and calcium-based phosphate binders on uric acid concentrations in patients undergoing hemodialysis: A randomized clinical trial. Arthritis Rheum 2005; 52:290-5.

Ferramosca E, Burke S, Chasan-Taber S, Ratti C, Chertow GM, Raggi P. Potential antiatherogenic and anti-inflammatory properties of sevelamer in maintenance hemodialysis patients. Am Heart J 2005;
149:820-5.

Protocol ICR013769

Burke SK, Amin NS, Incerti C, Plone MA, Watson N. Sevelamer Hydrochloride (Renagel^®), a nonabsorbed phosphate-binding polymer, does not interfere with digoxin or warfarin pharmacokinetics. Journal of Clinical Pharmacology 2001; 41:193-198.

Protocol ICR013821

Burke SK, Amin NS, Incerti C, Plone MA, Watson N. Sevelamer Hydrochloride (Renagel®), a nonabsorbed phosphate-binding polymer, does not interfere with digoxin or warfarin pharmacokinetics. Journal of Clinical Pharmacology 2001; 41:193-198.

Protocol REN-001-00

Asmus HG, Braun J, Krause R, Brunkhorst R, Holzer H, Schulz W, Neumayer HH, Raggi P, Bommer J. Two year comparison of sevelamer and calcium carbonate effects on cardiovascular calcification and bone density. Nephrol Dial Transplant 2005;20:1653-61.

Protocol REN-002-01

No associated publications.