AMG 416 (velcalcetide) is a novel peptide for the treatment of secondary hyperparathyroidism in a single-dose study in hemodialysis patients

Kidney International

Volumn 85, Issue 1, 2014, Pages 191-197

  Martin, Kevin J ^a   Pickthorn, Karen ^b   Huang, Saling ^b   Block, Geoffrey A ^c   Vick, Andrew ^d   Mount, Peter F ^e   Power, David A ^e   Bell, Gregory ^b,f  

^a SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b AMGEN INC   (United States)

^c Denver Nephrology   (United States)

^d WIL RESEARCH LABORATORIES   (United States)

^e AUSTIN HOSPITAL   (Australia)

^f UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

bone; calcium; calcium sensing receptor; hemodialysis; hyperparathyroidism; parathyroid hormone

Indexed keywords

CALCIUM; FIBROBLAST GROWTH FACTOR 23; PARATHYROID HORMONE; PHOSPHATE; PLACEBO; VELCALCETIDE; VITAMIN D DERIVATIVE;

ADULT; AGED; ANEMIA; ARTICLE; CALCIUM BLOOD LEVEL; CLINICAL ARTICLE; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; GASTROESOPHAGEAL REFLUX; HEMODIALYSIS; HEMODIALYSIS PATIENT; HOSPITAL ADMISSION; HOSPITAL DISCHARGE; HUMAN; MALE; MIDDLE AGED; PARATHYROID HORMONE BLOOD LEVEL; PARESTHESIA; PHOSPHATE BLOOD LEVEL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCREENING; SECONDARY HYPERPARATHYROIDISM; SINGLE DRUG DOSE; TOOTH PAIN; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; HYPERPARATHYROIDISM, SECONDARY; INJECTIONS, INTRAVENOUS; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; PEPTIDES; RENAL DIALYSIS;

EID: 84891559221     PISSN: 00852538     EISSN: 15231755     Source Type: Journal    
DOI: 10.1038/ki.2013.289     Document Type: Article

References (34)

1. Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol 2011; 6: 913-921.
2. US Renal Data System. USRDS 2009 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases: Bethesda, MD, 2009.
3. Alem AM, Sherrard DJ, Gillen DL et al. Increased risk of hip fracture among patients with end-stage renal disease. Kidney Int 2000; 58: 396-399. (Pubitemid 30429887)
4. 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: 1226-1237. (Pubitemid 30354431)
5. Bro S, Olgaard K. Effects of excess PTH on nonclassical target organs. Am J Kidney Dis 1997; 30: 606-620. (Pubitemid 27465354)
6. Diaz-Corte C, Cannata-Andia JB. Management of secondary hyperparathyroidism: the gap between diagnosis and treatment. The Renal Osteodystrophy Multicenter Enquiry. Am J Med Sci 2000; 320: 107-111. (Pubitemid 30664183)
7. Moe SM. Current issues in the management of secondary hyperparathyroidism and bone disease. Perit Dial Int 2001; 21(Suppl 3): S241-S246. (Pubitemid 34406812)
8. Salusky IB, Goodman WG. The management of renal osteodystrophy. Pediatr Nephrol 1996; 10: 651-653. (Pubitemid 26331785)
9. Slatopolsky E, Martin K, Hruska K. Parathyroid hormone metabolism and its potential as a uremic toxin. Am J Physiol 1980; 239: F1-12.
10. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42: S1-201.
11. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl 2009; S1-S130.
12. Elder G, Faull R, Branley P et al. The CARI guidelines. Management of bone disease, calcium, phosphate and parathyroid hormone. Nephrology (Carlton) 2006; 11(Suppl 1): S230-S261.
13. Kazama JJ. Japanese Society of Dialysis Therapy treatment guidelines for secondary hyperparathyroidism. Ther Apher Dial 2007; 11(Suppl 1): S44-S47. (Pubitemid 350043952)
14. Uhlig K, Berns JS, Kestenbaum B et al. KDOQI US commentary on the 2009 KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of CKD-Mineral and Bone Disorder (CKD-MBD). Am J Kidney Dis 2010; 55: 773-799.
15. Meir T, Levi R, Lieben L et al. Deletion of the vitamin D receptor specifically in the parathyroid demonstrates a limited role for the receptor in parathyroid physiology. Am J Physiol Renal Physiol 2009; 297: F1192-F1198.
16. Silver J, Moallem E, Kilav R et al. Regulation of the parathyroid hormone gene by calcium, phosphate and 1,25-dihydroxyvitamin D. Nephrol Dial Transplant 1998; 13(Suppl 1): 40-44. (Pubitemid 28059579)
17. Brown EM, Gamba G, Riccardi D et al. Cloning and characterization of an extracellular Ca(2)-sensing receptor from bovine parathyroid. Nature 1993; 366: 575-580. (Pubitemid 24035999)
18. Nemeth EF, Heaton WH, Miller M et al. Pharmacodynamics of the type II calcimimetic compound cinacalcet HCl. J Pharmacol Exp Ther 2004; 308: 627-635. (Pubitemid 38134225)
19. Block GA, Martin KJ, de Francisco AL et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004; 350: 1516-1525. (Pubitemid 38477776)
20. Walter S, Baruch A, Alexander S et al. AMG 416, a novel peptide agonist of the calcium-sensing receptor, is active in rodent models of uremia. Submitted.
21. Walter S, Baruch A, Dong J et al. Pharmacology of AMG 416 (velcalcetide), a novel peptide agonist of the calcium sensing receptor, for the treatment of secondary hyperparathyroidism in hemodialysis patients. J Pharmacol Exp Ther 2013; 346: 229-240.
22. Martin KJ, Bell G, Pickthorn K et al. AMG 416, a novel peptide agonist of the calcium sensing receptor, reduces serum parathyroid hormone and FGF23 levels in healthy male subjects. Submitted.
23. Kurosu H, Ogawa Y, Miyoshi M et al. Regulation of fibroblast growth factor-23 signaling by klotho. J Biol Chem 2006; 281: 6120-6123. (Pubitemid 43847540)
24. Urakawa I, Yamazaki Y, Shimada T et al. Klotho converts canonical FGF receptor into a specific receptor for FGF23. Nature 2006; 444: 770-774. (Pubitemid 44949607)
25. Faul C, Amaral AP, Oskouei B et al. FGF23 induces left ventricular hypertrophy. J Clin Invest 2011; 121: 4393-4408.
26. Gutierrez OM. Fibroblast growth factor 23 and disordered vitamin D metabolism in chronic kidney disease: updating the 'trade-off' hypothesis. Clin J Am Soc Nephrol 2010; 5: 1710-1716.
27. Komaba H, Fukagawa M. FGF23-parathyroid interaction: implications in chronic kidney disease. Kidney Int 2010; 77: 292-298.
28. Gincherman Y, Moloney K, McKee C et al. Assessment of adherence to cinacalcet by prescription refill rates in hemodialysis patients. Hemodial Int 2010; 14: 68-72.
29. Koizumi M, Komaba H, Nakanishi S et al. Cinacalcet treatment and serum FGF23 levels in haemodialysis patients with secondary hyperparathyroidism. Nephrol Dial Transplant 2012; 27: 784-790.
30. Liu S, Tang W, Zhou J et al. Fibroblast growth factor 23 is a counterregulatory phosphaturic hormone for vitamin D. J Am Soc Nephrol 2006; 17: 1305-1315. (Pubitemid 43673410)
31. Nishi H, Nii-Kono T, Nakanishi S et al. Intravenous calcitriol therapy increases serum concentrations of fibroblast growth factor-23 in dialysis patients with secondary hyperparathyroidism. Nephron Clin Pract 2005; 101: c94-c99. (Pubitemid 41208897)
32. Fliser D, Kollerits B, Neyer U et al. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol 2007; 18: 2600-2608.
33. Jean G, Bresson E, Terrat JC et al. Peripheral vascular calcification in longhaemodialysis patients: associated factors and survival consequences. Nephrol Dial Transplant 2009; 24: 948-955.
34. Gutierrez OM, Mannstadt M, Isakova T et al. Fibroblast growth factor 23 and mortality among patients undergoing hemodialysis. N Engl J Med 2008; 359: 584-592.