Rationale, design, and characteristics of a trial to evaluate the new phosphate iron-based binder sucroferric oxyhydroxide in dialysis patients with the goal of advancing the practice of E.B.M. (EPISODE)

Clinical and Experimental Nephrology

Volumn 22, Issue 4, 2018, Pages 967-972

  Isaka, Yoshitaka ^a   Fujii, Hideki ^b   Tsujimoto, Yoshihiro ^c   Teramukai, Satoshi ^d   Hamano, Takayuki ^a  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b KOBE UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c Inoue Hospital   (Japan)

^d KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

Author keywords

Coronary artery calcification score; Dialysis patient; Hyperphosphatemia; Multi detector computed tomography; Phosphate binder

Indexed keywords

IRON; LANTHANUM CARBONATE; PHOSPHATE; PHOSPHATE BINDING AGENT; SUCROFERRIC OXYHYDROXIDE; CHELATING AGENT; FERRIC ION; SUCROSE;

ADULT; AGED; ARTICLE; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CORONARY ARTERY CALCIFICATION; CORONARY ARTERY CALCIUM SCORE; CORONARY RISK; FACTORIAL DESIGN; FEMALE; HEMODIALYSIS PATIENT; HUMAN; INTERVENTION STUDY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHOSPHATE BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL; CALCINOSIS; COMPLICATION; CORONARY ARTERY DISEASE; DRUG COMBINATION; HEMODIALYSIS; HYPERPHOSPHATEMIA; RANDOMIZED CONTROLLED TRIAL (TOPIC);

CALCINOSIS; CHELATING AGENTS; CORONARY ARTERY DISEASE; DRUG COMBINATIONS; FERRIC COMPOUNDS; HUMANS; HYPERPHOSPHATEMIA; IRON; PHOSPHATES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENAL DIALYSIS; SUCROSE;

EID: 85043682916     PISSN: 13421751     EISSN: 14377799     Source Type: Journal    
DOI: 10.1007/s10157-018-1547-5     Document Type: Article

References (13)

1. Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension (Dallas: 1979) 2001;38:938–42
2. Taniguchi M, Fukagawa M, Fujii N, Hamano T, Shoji T, Yokoyama K, Nakai S, Shigematsu T, Iseki K, Tsubakihara Y. Serum phosphate and calcium should be primarily and consistently controlled in prevalent hemodialysis patients. Therapeutic apheresis and dialysis: official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis. Jpn Soc Dial Therapy. 2013;17:221–8
3. Isakova T, Gutierrez OM, Chang Y, Shah A, Tamez H, Smith K, Thadhani R, Wolf M. Phosphorus binders and survival on hemodialysis. J Am Soc Nephrol: JASN. 2009;20:388–96
4. Kalil RS, Flanigan M, Stanford W, Haynes WG. Dissociation between progression of coronary artery calcification and endothelial function in hemodialysis patients: a prospective pilot study. Clin Nephrol. 2012;78:1–9
5. Ohtake T, Kobayashi S, Oka M, Furuya R, Iwagami M, Tsutsumi D, Mochida Y, Maesato K, Ishioka K, Moriya H, Hidaka S. Lanthanum carbonate delays progression of coronary artery calcification compared with calcium-based phosphate binders in patients on hemodialysis: a pilot study. J Cardiovasc Pharmacol Ther. 2013;18:439–46
6. Toussaint ND, Lau KK, Polkinghorne KR, Kerr PG. Attenuation of aortic calcification with lanthanum carbonate versus calcium-based phosphate binders in haemodialysis: a pilot randomized controlled trial. Nephrology (Carlton Vic). 2011;16:290–8
7. Floege J, Covic AC, Ketteler M, Mann JF, Rastogi A, Spinowitz B, Chong EM, Gaillard S, Lisk LJ, Sprague SM. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association. Eur Renal Assoc. 2015;30:1037–46
8. Hergesell O, Ritz E. Stabilized polynuclear iron hydroxide is an efficient oral phosphate binder in uraemic patients. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association. Eur Renal Assoc. 1999;14:863–7
9. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245–52
10. Hutchison AJ, Barnett ME, Krause R, Kwan JT, Siami GA. Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment. Nephron Clin Pract. 2008;110:c15-23
11. Hutchison AJ, Maes B, Vanwalleghem J, Asmus G, Mohamed E, Schmieder R, Backs W, Jamar R, Vosskuhler A. Efficacy, tolerability, and safety of lanthanum carbonate in hyperphosphatemia: a 6-month, randomized, comparative trial versus calcium carbonate. Nephron Clin Pract. 2005;100:c8-19
12. Floege J, Covic AC, Ketteler M, Rastogi A, Chong EM, Gaillard S, Lisk LJ, Sprague SM. A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients. Kidney Int. 2014;86:638–47
13. Phan O, Maillard M, Peregaux C, Mordasini D, Stehle JC, Funk F, Burnier M. PA21, a new iron-based noncalcium phosphate binder, prevents vascular calcification in chronic renal failure rats. J Pharmacol Exp Ther. 2013;346:281–9