Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: Results of a randomized, double-blind, placebo-controlled trial

American Journal of Nephrology

Volumn 36, Issue 5, 2012, Pages 478-487

  Yokoyama, Keitaro ^a   Hirakata, Hideki ^c   Akiba, Takashi ^b   Sawada, Kenichi ^d   Kumagai, Yuji ^e  

^a JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^c FUKUOKA RED CROSS HOSPITAL   (Japan)

^d AKITA UNIVERSITY   (Japan)

^e KITASATO UNIVERSITY HOSPITAL   (Japan)

Author keywords

Ferric citrate hydrate; Hemodialysis; Hyperphosphatemia

Indexed keywords

CALCIUM; FERRIC CITRATE; JTT 751; PARATHYROID HORMONE; PHOSPHORUS; PLACEBO; TRANSFERRIN; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ARTICLE; CALCIUM BLOOD LEVEL; CHRONIC KIDNEY DISEASE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DUODENUM ULCER; FEMALE; GASTROENTERITIS; HEMATOLOGICAL PARAMETERS; HEMODIALYSIS PATIENT; HEMORRHAGIC GASTRITIS; HERPES ZOSTER; HUMAN; HYPERPHOSPHATEMIA; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARATHYROID HORMONE BLOOD LEVEL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; TRANSFERRIN SATURATION;

DOUBLE-BLIND METHOD; FEMALE; FERRIC COMPOUNDS; HUMANS; HYPERPHOSPHATEMIA; MALE; MIDDLE AGED; RENAL DIALYSIS;

EID: 84868605052     PISSN: 02508095     EISSN: 14219670     Source Type: Journal    
DOI: 10.1159/000344008     Document Type: Article

References (27)

1. Hruska K A, Mathew S, Lund R, et al: Hyper-phosphatemia of chronic kidney disease. Kidney Int 2008; 74:148-155.
2. Braun J, Oldendorf M, Moshage W, et al: Electron beam computed tomography in the evaluation of cardiac calcification in chronic dialysis patients. Am J Kidney Dis 1996; 27: 394-401.
3. Sarnak MJ: Cardiovascular complications in chronic kidney disease. Am J Kidney Dis 2003; 41(5 suppl):11-17.
4. The Japanese Society for Dialysis Therapy: Guidelines for the management of secondary hyperparathyroidism in chronic dialysis patients. J Jpn Soc Dial Ther 2006; 39:1435-1455.
5. Moe S, Drüeke T, Cunningham J, et al: Kidney Disease. Improving Global Outcomes (KDIGO): Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int 2006; 69: 1945-1953.
6. Martin KJ, González EA: Prevention and control of phosphate retention/hyperphos-phatemia in CKD-MBD: what is normal, when to start, and how to treat. Clin J Am Soc Nephrol 2011; 6:440-446.
7. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003 (4 suppl 3):S1-S201.
8. Hsu CH: Are we mismanaging calcium and phosphate metabolism in renal failure? Am J Kidney Dis 1997; 29:641-649.
9. Clarkson EM, Eastwood JB, Koutsaimanis KG, de Wandener HE: Net intestinal absorption of calcium in patients with chronic renal fa ilure. Kidney Int 1973; 3: 258-263.
10. Nolan CR, Qunibi WY: Calcium salts in the treatment of hyperphosphatemia in hemodi-alysis patients. Curr Opin Nephrol Hyper-tens 2003; 12: 373-379.
11. Suzuki A, Ohyama Y, Sezaimaru S, et al: Adequate use of sevelamer hydrochloride. J Jpn Soc Dial Ther 2004; 37: 1008.
12. Tsuda I, Kukita K, Imamura E, et al: Study of administration of sevelamer hydrochloride in hemodialysis patients with hyperphos-phatemia. J Jpn Soc Dial Ther 2004; 37: 803.
13. Tatsuta K, Shigematsu T: Management of phosphate in chronic kidney disease-clinical trials of lanthanum carbonatet. Clin Calcium 2009; 19: 219-223.
14. Ritz E, Hergesell O: Oral phosphate binders without aluminium and calcium-a pipe-dream? Nephrol Dial Transplant 1996; 11: 766-768.
15. Hergesell O, Ritz E: Stabilized polynuclear iron hydroxide is an efficient oral phosphate binder in uraemic patients. Nephrol Dial Transplant 1999; 14:863-867.
16. Hsu CH, Patel SR, Young EW: New phosphate binding agents: ferric compounds. J Am Soc Nephrol 1999; 10:1274-1280.
17. Yang WC, Yang CS, Hou CC, et al: An open-label, crossover study of a new phosphate-binding agent in haemodialysis patients: ferric citrate. Nephrol Dial Transplant 2002; 17: 265-270.
18. Block GA, Brillhart SL, Persky MS, et al: Efficacy and safety of SBR759, a new iron-based phosphate binder. Kidney Int 2010; 77: 897-903.
19. Chen JB, Chiang SS, Chen HC, et al: Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphorus binder, in Asian patients undergoing hemodialysis: a 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton) 2011; 16:743-750.
20. Geisser P, Philipp E: PA21: a novel phosphate binder for the treatment of hyperphosphate-mia in chronic kidney disease. Clin Nephrol 2010; 74: 4-11.
21. Code of Federal Regulations: Title 21, Part 184 Direct Food Substances Affirmed as Generally Recognized as Safe, Section 184.1298 (Ferric citrate). Available at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecf r&sid=9447f82d8b983305ff31235ae4d91621 &rgn=div8& view=text&node=21: 3.0.1.1.14. 2.1.75&idno=21 (accessed 06/07/2012)
22. Shigematsu T: Lanthanum carbonate effectively controls serum phosphate without affecting serum calcium levels in patients undergoing hemodialysis. Ther Apher Dial 2008; 12:55-61.
23. Shigematsu T: Multicenter prospective randomized, double-blind comparative study between lanthanum carbonate and calcium carbonate as phosphate binders in Japanese hemodialysis patients with hyperphosphate-mia. Clin Nephrol 2008; 70:404-410.
24. Bond CT, Mutell R, Wang S, et al: Ferric citrate: an iron-based oral phosphate binder. Kidney Res Clin Pract 2012; 31:A38-A39.
25. McFarlane PA, Pisoni RL, Eichleay MA, et al: International trends in erythropoietin use and hemoglobin levels in hemodialysis patients. Kidney Int 2010; 78:215-223.
26. Iain CM: Startegies for iron supplementation: oral versus intravenous. Kidney Int 1999; 55:S61-S66.
27. Hasegawa T, Bragg-Gresham JL, Pisoni RL, et al: Changes in anemia management and hemoglobin levels following revision of a bundling policy to incorporate recombinant huma n er y thropoietin. Kidney Int 2011; 79: 340-346.