A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients

Kidney International

Volumn 86, Issue 3, 2014, Pages 638-647

  Floege, Jürgen ^a   Covic, Adrian C ^b   Ketteler, Markus ^c   Rastogi, Anjay ^d   Chong, Edward M F ^e   Gaillard, Sylvain ^e   Lisk, Laura J ^e   Sprague, Stuart M ^f  

^a UNIVERSITY HOSPITAL RWTH AACHEN   (Germany)

^b GRIGORE T POPA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^c KfH Kidney Center Coburg   (Germany)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e Vifor (International) Inc   (Switzerland)

^f NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

Author keywords

adherence; dialysis; hyperphosphatemia; PA21; phosphate binder; sevelamer

Indexed keywords

C REACTIVE PROTEIN; FERRITIN; HEMOGLOBIN; IRON; PHOSPHORUS; SEVELAMER CARBONATE; SUCROFERRIC OXYHYDROXIDE; TRANSFERRIN; CHELATING AGENT; FERRIC ION; PA21 COMPOUND; POLYAMINE; SEVELAMER;

ABDOMINAL DISCOMFORT; ABNORMAL FECES; ADULT; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISCOLORED FECES; DISEASE CONTROL; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DUODENUM ULCER; FEMALE; FERRITIN BLOOD LEVEL; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HEMODIALYSIS; HEMODIALYSIS PATIENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERPHOSPHATEMIA; HYPERTENSION; IRON BLOOD LEVEL; LOW DRUG DOSE; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PARALLEL DESIGN; PATIENT ATTITUDE; PATIENT COMPLIANCE; PERITONEAL DIALYSIS; PHARMACOLOGICAL PARAMETERS; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PILL BURDEN; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TABLET; TRANSFERRIN BLOOD LEVEL; UPPER ABDOMINAL PAIN; VOMITING; AGED; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPLICATION; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; MEDICATION COMPLIANCE; MIDDLE AGED; PATIENT DROPOUTS; RENAL INSUFFICIENCY, CHRONIC;

ADULT; AGED; CHELATING AGENTS; CONSTIPATION; DIARRHEA; FEMALE; FERRIC COMPOUNDS; HUMANS; HYPERPHOSPHATEMIA; INDUCTION CHEMOTHERAPY; MAINTENANCE CHEMOTHERAPY; MALE; MEDICATION ADHERENCE; MIDDLE AGED; NAUSEA; PATIENT DROPOUTS; PERITONEAL DIALYSIS; PHOSPHORUS; POLYAMINES; RENAL INSUFFICIENCY, CHRONIC;

EID: 84907597180     PISSN: 00852538     EISSN: 15231755     Source Type: Journal    
DOI: 10.1038/ki.2014.58     Document Type: Article

References (25)

1. Hruska KA, Mathew S. The roles of the skeleton and phosphorus in the CKD mineral bone disorder. Adv Chronic Kidney Dis 2011; 18: 98-104.
2. Block GA. Control of serum phosphorus: implications for coronary artery calcification and calcific uremic arteriolopathy (calciphylaxis). Curr Opin Nephrol Hypertens 2001; 10: 741-747.
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. Palmer SC, Hayen A, Macaskill P et al. Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis. JAMA 2011; 305: 1119-1127.
5. Kanbay M, Goldsmith D, Akcay A et al. Phosphate - the silent stealthy cardiorenal culprit in all stages of chronic kidney disease: a systematic review. Blood Purif 2009; 27: 220-230.
6. Tentori F, Blayney MJ, Albert JM et al. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2008; 52: 519-530.
7. Isakova T, Gutierrez OM, Chang Y et al. Phosphorus binders and survival on hemodialysis. J Am Soc Nephrol 2009; 20: 388-396.
8. Lopes AA, Tong L, Thumma J et al. Phosphate binder use and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS): Evaluation of Possible Confounding by Nutritional Status. Am J Kidney Dis 2012; 60: 90-101.
9. Arenas MD, Malek T, Gil MT et al. Challenge of phosphorus control in hemodialysis patients: a problem of adherence? J Nephrol 2010; 23: 525-534.
10. Chiu YW, Teitelbaum I, Misra M et al. Pill burden, adherence, hyperphosphatemia, and quality of life in maintenance dialysis patients. Clin J Am Soc Nephrol 2009; 4: 1089-1096.
11. Wang S, Alfieri T, Braunhofer P et al. Pill burden and its Association with Medication Possession Ratio Among Hemodialysis Patients with Hyperphosphatemia. Abstract presented at the European Renal Association - European Dialysis and Transplantation Association Annual Meeting; 24-27 May 2012. Paris, France.
12. Geisser P, Philipp E. PA21: a novel phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease. Clin Nephrol 2010; 74: 4-11.
13. Hergesell O, Ritz E. Stabilized polynuclear iron hydroxide is an efficient oral phosphate binder in uraemic patients. Nephrol Dial Transplant 1999; 14: 863-867.
14. Wuthrich RP, Chonchol M, Covic A et al. Randomized clinical trial of the iron-based phosphate binder PA21 in hemodialysis patients. Clin J Am Soc Nephrol 2013; 8: 280-289.
15. Tentori F, Karaboyas A, Bieber B et al. Self-reported non-adherence with phosphate binder prescription is associated with high serum phosphorus and PTH: results from the DOPPS [abstract]. J Am Soc Nephrol 2012; 23: 793A.
16. Karamanidou C, Clatworthy J, Weinman J et al. A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease. BMC Nephrol 2008; 9: 2.
17. Denhaerynck K, Manhaeve D, Dobbels F et al. Prevalence and consequences of nonadherence to hemodialysis regimens. Am J Crit Care 2007; 16: 222-235.
18. Bond C, Wang S, Alfieri T et al. Pill Burden and its Association with Medication Possession Ratio Among Hemodialysis Patients with Hyperphosphatemia. Abstract presented at the 49th Annual Meeting of the European Renal Association - European Dialysis and Transplantation Association; 24-27 May 2012. Paris, France.
19. Alfieri T, Wang S, Braunhofer P et al. Reasons for phosphate binder discontinuation vary by binder type [Abstract]. J Am Soc Nephrol 2012; 23: 793A.
20. Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis 2007; 14: 82-99.
21. Renvela® (sevelamer carbonate). Prescribing Information. Genzyme Corporation: Cambridge, MA, 2011.
22. Sinsakul M, Sika M, Koury M et al. The safety and tolerability of ferric citrate as a phosphate binder in dialysis patients. Nephron Clin Pract 2012; 121: c25-c29.
23. Pisoni RL, Fuller DS, Bieber BA et al. The DOPPS Practice Monitor for US dialysis care: trends through August 2011. Am J Kidney Dis 2012; 60: 160-165.
24. Dwyer JP, Sika M, Schulman G et al. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis 2013; 61: 759-766.
25. Sinsakul M, Sika M, Koury M et al. The safety and tolerability of ferric citrate as a phosphate binder in dialysis patients. Nephron Clin Pract 2012; 121: c25-c29.