No effect of renal function or dialysis on pharmacokinetics of cinacalcet (Sensipar®/Mimpara®)

Clinical Pharmacokinetics

Volumn 44, Issue 5, 2005, Pages 509-516

  Padhi, Desmond ^a   Harris, Robert Z ^a   Salfi, Margaret ^a   Sullivan, John T ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIMIMETIC AGENT; CALCIUM; CINACALCET; PARATHYROID HORMONE;

ADULT; AGED; ARTICLE; CALCIUM BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS AMBULATORY PERITONEAL DIALYSIS; DIARRHEA; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG PROTEIN BINDING; DYSPEPSIA; FEMALE; GASTROINTESTINAL SYMPTOM; HEMODIALYSIS; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; NAUSEA; OPEN STUDY; PARATHYROID HORMONE BLOOD LEVEL; PHARMACODYNAMICS; PRIORITY JOURNAL; SECONDARY HYPERPARATHYROIDISM; SINGLE DRUG DOSE;

ADULT; AGED; CALCIUM; FEMALE; HUMANS; KIDNEY DISEASES; MALE; MIDDLE AGED; NAPHTHALENES; PARATHYROID HORMONE; RENAL DIALYSIS;

EID: 19544367799     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-200544050-00004     Document Type: Article

References (20)

1. Nemeth EF. Calcium receptors as novel drug targets. In: Bilezikian JP, Raisz LG, Rodan GA, editors. Principles in bone biology. San Diego (CA): San Diego Academic Press, 1996: 1019-35
2. Garrett JE, Capuano IV, Hammerland LG, et al. Molecular cloning and functional expression of human parathyroid calcium receptor cDNAs. J Biol Chem 1995; 270 (21): 12919-25
3. Quarles LD, Sherrard DJ, Adler S, et al. The calcimimetic AMG 073 as a potential treatment for secondary hyperparathyroidism of end-stage renal disease. J Am Soc Nephrol 2003; 14 (3): 575-83
4. Lindberg JS, Moe SM, Goodman WG, et al. The calcimimetic AMG 073 reduces parathyroid hormone and calcium × phosphorus in secondary hyperparathyroidism. Kidney Int 2003; 63 (1): 248-54
5. Goodman WG, Hladik GA, Turner SA, et al. The calcimimetic agent AMG 073 lowers plasma parathyroid hormone levels in hemodialysis patients with secondary hyperparathyroidism. J Am Soc Nephrol 2002; 13 (4): 1017-24
6. Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004; 350 (15): 1516-25
7. Voigts A, Felsenfeld AJ, Andress D, et al. Parathyroid hormone and bone histology: response to hypocalcemia in osteitis fibrosa. Kidney Int 1984; 25 (2): 445-52
8. Wang M, Hercz G, Sherrard DJ, et al. Relationship between intact 1-84 parathyroid hormone and bone histomorphometric parameters in dialysis patients without aluminum toxicity. Am J Kidney Dis 1995; 26 (5): 836-44
9. Block GA, Hulbert-Shearon TE, Levin NW, et al. Association of serum phosphorus and calcium × phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis 1998; 31 (4): 607-17
10. Alem AM, Sherrard DJ, Gillen DL, et al. Increased risk of hip fracture among patients with end-stage renal disease. Kidney Int 2000; 58(1): 396-9
11. Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis 2000; 35 (6): 1226-37
12. Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med 2000; 342 (20): 1478-83
13. Rix M, Andreassen H, Eskildsen P, et al. Bone mineral density and biochemical markers of bone turnover in patients with predialysis chronic renal failure. Kidney Int 1999; 56 (3): 1084-93
14. Vanholder R, De Smet R, Ringoir S. Factors influencing drug protein binding in patients with end stage renal failure. Eur J Clin Pharmacol 1993; 44 Suppl. 1: S17-21
15. Guidance for industry: pharmacokinetics in patients with impaired renal function: study design, data analysis, and impact on dosing and labelling. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, 1998 May
16. Harris RZ, Padhi D, Marbury TC, et al. Pharmacokinetics, pharmacodynamics, and safety of cinacalcet HCl in hemodialysis patients at doses up to 200mg once daily. Am J Kidney Dis 2004; 44 (6): 1070-6
17. Ings RMJ. Pharmacokinetics and its application to drug development. In: Illing HPA, editor. Xenobiotic metabolism and disposition: the design of studies on novel compounds. Boca Raton (FL): CRC Press, 1989: 99-146
18. Padhi D, Harris R, Salfi M, et al. The pharmacokinetics of cinacalcet HCl are not altered by renal impairment or mode of renal replacement therapy [abstract]. World Congress of Nephrology Meeting; 2003 Jun 8-12; Berlin
19. Padhi D, Harris R, Salfi M, et al. Cinacalcet HCl absorption is not affected by coadministration of medications commonly prescribed to chronic kidney disease patients (pantoprazole sodium, sevelamer HCl, and calcium carbonate) [abstract]. American Society of Nephrology Meeting; 2003 Nov 12-17; San Diego
20. Sensipar® package insert. Thousand Oaks (CA): Amgen Inc., 2004