A randomized study evaluating cinacalcet to treat hypercalcemia in renal transplant recipients with persistent hyperparathyroidism

American Journal of Transplantation

Volumn 14, Issue 11, 2014, Pages 2545-2555

  Evenepoel, P ^a   Cooper, K ^b   Holdaas, H ^c   Messa, P ^d   Mourad, G ^e   Olgaard, K ^f   Rutkowski, B ^g   Schaefer, H ^h   Deng, H ^b   Torregrosa, J V ⁱ   Wuthrich, R P ^j   Yue, S ^b  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b AMGEN INC   (United States)

^c OSLO UNIVERSITY HOSPITAL   (Norway)

^d FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^e LAPEYRONIE HOSPITAL   (France)

^f UNIVERSITY OF COPENHAGEN   (Denmark)

^g MEDICAL UNIVERSITY OF GDANSK   (Poland)

^h VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF BARCELONA   (Spain)

^j UNIVERSITY HOSPITAL ZURICH   (Switzerland)

more..

Author keywords

Clinical research practice; hyperparathyrodism; kidney disease; kidney disease: metabolic; kidney transplantation nephrology; kidney transplantation: living donor

Indexed keywords

CALCIUM; CINACALCET; PHOSPHORUS; PLACEBO; NAPHTHALENE DERIVATIVE;

ADULT; ARTICLE; BONE DENSITY; BONE TURNOVER; CALCIUM BLOOD LEVEL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEMUR NECK; FOOT FRACTURE; HUMAN; HYPERCALCEMIA; HYPERPARATHYROIDISM; HYPOPHOSPHATEMIA; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERSISTENT HYPERPARATHYROIDISM; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; POSTOPERATIVE COMPLICATION; RANDOMIZED CONTROLLED TRIAL; SPINE FRACTURE; SURGICAL PATIENT; TREATMENT OUTCOME; BLOOD; BONE REMODELING; COMPLICATION; MIDDLE AGED;

ADULT; BONE DENSITY; BONE REMODELING; CALCIUM; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPERCALCEMIA; HYPERPARATHYROIDISM; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; NAPHTHALENES; PHOSPHORUS; PLACEBOS;

EID: 84911985198     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/ajt.12911     Document Type: Article

References (56)

1. Sayegh MH, Carpenter CB., Transplantation 50 years later-Progress, challenges, and promises. N Engl J Med 2004; 351: 2761-2766.
2. Marechal C, Coche E, Goffin E, et al. Progression of coronary artery calcification and thoracic aorta calcification in kidney transplant recipients. Am J Kidney Dis 2012; 59: 258-269.
3. Mazzaferro S, Pasquali M, Taggi F, et al. Progression of coronary artery calcification in renal transplantation and the role of secondary hyperparathyroidism and inflammation. Clin J Am Soc Nephrol 2009; 4: 685-690.
4. Giannini S, Sella S, Silva Netto F, et al. Persistent secondary hyperparathyroidism and vertebral fractures in kidney transplantation: Role of calcium-sensing receptor polymorphisms and vitamin D deficiency. J Bone Miner Res 2010; 25: 841-848.
5. Perrin P, Caillard S, Javier RM, et al. Persistent hyperparathyroidism is a major risk factor for fractures in the 5 years after kidney transplantation. Am J Transplant 2013; 13: 2653-2663.
6. Drueke TB., Therapeutic failure of cinacalcet in a renal transplant patient. Nephrol Dial Transplant 2006; 21: 824; author reply 824-825.
7. Block GA, Zeig S, Sugihara J, et al. Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrol Dial Transplant 2008; 23: 2311-2318.
8. Cunningham J, Locatelli F, Rodriguez M., Secondary hyperparathyroidism: Pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol 2011; 6: 913-921.
9. Moe SM, Chertow GM, Coburn JW, et al. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int 2005; 67: 760-771.
10. Evenepoel P, Claes K, Kuypers D, et al. Natural history of parathyroid function and calcium metabolism after kidney transplantation: A single-centre study. Nephrol Dial Transplant 2004; 19: 1281-1287.
11. Stavroulopoulos A, Cassidy MJ, Porter CJ, et al. Vitamin D status in renal transplant recipients. Am J Transplant 2007; 7: 2546-2552.
12. Torregrosa JV, Bergua C, Martinez de Osaba MJ, et al. Evolution of secondary hyperparathyroidism after kidney transplantation in patients receiving cinacalcet on dialysis. Transplant Proc 2009; 41: 2396-2398.
13. Serra AL, Wuhrmann C, Wuthrich RP., Phosphatemic effect of cinacalcet in kidney transplant recipients with persistent hyperparathyroidism. Am J Kidney Dis 2008; 52: 1151-1157.
14. Trombetti A, Richert L, Hadaya K, et al. Early post-transplantation hypophosphatemia is associated with elevated FGF-23 levels. Eur J Endocrinol 2011; 164: 839-847.
15. Meneghini M, Regalia A, Alfieri C, et al. Calcium and osteoprotegerin levels predict the progression of the abdominal aortic calcifications after kidney transplantation. Transplantation 2013; 96: 42-48.
16. Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349: 2326-2333.
17. Schwarz A, Mengel M, Gwinner W, et al. Risk factors for chronic allograft nephropathy after renal transplantation: A protocol biopsy study. Kidney Int 2005; 67: 341-348.
18. Sarnak MJ, Levey AS., Cardiovascular disease and chronic renal disease: A new paradigm. Am J Kidney Dis 2000; 35: S117-S131.
19. Evenepoel P, Claes K, Kuypers D, et al. Impact of parathyroidectomy on renal graft function, blood pressure and serum lipids in kidney transplant recipients: A single centre study. Nephrol Dial Transplant 2005; 20: 1714-1720.
20. Evenepoel P, Kuypers D, Maes B, et al. Persistent hyperparathyroidism after kidney transplantation requiring parathyroidectomy. Acta Otorhinolaryngol Belg 2001; 55: 177-186.
21. 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.
22. El-Amm JM, Doshi MD, Singh A, et al. Preliminary experience with cinacalcet use in persistent secondary hyperparathyroidism after kidney transplantation. Transplantation 2007; 83: 546-549.
23. Leca N, Laftavi M, Gundroo A, et al. Early and severe hyperparathyroidism associated with hypercalcemia after renal transplant treated with cinacalcet. Am J Transplant 2006; 6: 2391-2395.
24. Apostolou T, Damianou L, Kotsiev V, et al. Treatment of severe hypercalcemia due to refractory hyperparathyroidism in renal transplant patients with the calcimimetic agent cinacalcet. Clin Nephrol 2006; 65: 374-377.
25. Bergua C, Torregrosa JV, Cofan F, et al. Cinacalcet for the treatment of hypercalcemia in renal transplanted patients with secondary hyperparathyroidism. Transplant Proc 2007; 39: 2254-2255.
26. Kruse AE, Eisenberger U, Frey FJ, et al. The calcimimetic cinacalcet normalizes serum calcium in renal transplant patients with persistent hyperparathyroidism. Nephrol Dial Transplant 2005; 20: 1311-1314.
27. Serra AL, Schwarz AA, Wick FH, et al. Successful treatment of hypercalcemia with cinacalcet in renal transplant recipients with persistent hyperparathyroidism. Nephrol Dial Transplant 2005; 20: 1315-1319.
28. Szwarc I, Argiles A, Garrigue V, et al. Cinacalcet chloride is efficient and safe in renal transplant recipients with posttransplant hyperparathyroidism. Transplantation 2006; 82: 675-680.
29. Henschkowski J, Bischoff-Ferrari HA, Wuthrich RP, et al. Renal function in patients treated with cinacalcet for persistent hyperparathyroidism after kidney transplantation. Kidney Blood Press Res 2011; 34: 97-103.
30. Westfall PH, Tobias RD, Rom D, et al. Multiple comparisons, multiple tests using SAS. Cary, NC: SAS Institute Inc., 1999.
31. Borstnar S, Erzen B, Gmeiner Stopar T, et al. Treatment of hyperparathyroidism with cinacalcet in kidney transplant recipients. Transplant Proc 2010; 42: 4078-4082.
32. Paschoalin RP, Torregrosa JV, Barros X, et al. Cinacalcet de novo in persistent hypercalcemia after kidney transplantation secondary to hyperparathyroidism: Long-term follow-up and effect of withdrawal. Transplant Proc 2012; 44: 2376-2378.
33. Pinho LR, Ribeiro Santos MJ, Pestana Vasconcelos M., Cinacalcet in the treatment of persistent hyperparathyroidism after kidney transplantation. Clin Nephrol 2011; 75: 263-268.
34. Sprague SM, Belozeroff V, Danese MD, et al. Abnormal bone and mineral metabolism in kidney transplant patients-A review. Am J Nephrol 2008; 28: 246-253.
35. Messa P, Sindici C, Cannella G, et al. Persistent secondary hyperparathyroidism after renal transplantation. Kidney Int 1998; 54: 1704-1713.
36. Evenepoel P., Recovery versus persistence of disordered mineral metabolism in kidney transplant recipients. Semin Nephrol 2013; 33: 191-203.
37. Eigelberger MS, Cheah WK, Ituarte PH, et al. The NIH criteria for parathyroidectomy in asymptomatic primary hyperparathyroidism: Are they too limited ? Ann Surg 2004; 239: 528-535.
38. Abdelhadi M, Nordenstrom J., Bone mineral recovery after parathyroidectomy in patients with primary and renal hyperparathyroidism. J Clin Endocrinol Metab 1998; 83: 3845-3851.
39. Sadideen HM, Taylor JD, Goldsmith DJ., Total parathyroidectomy without autotransplantation after renal transplantation for tertiary hyperparathyroidism: Long-term follow-up. Int Urol Nephrol 2012; 44: 275-281.
40. Abbott KC, Oglesby RJ, Hypolite IO, et al. Hospitalizations for fractures after renal transplantation in the United States. Ann Epidemiol 2001; 11: 450-457.
41. Nikkel LE, Hollenbeak CS, Fox EJ, et al. Risk of fractures after renal transplantation in the United States. Transplantation 2009; 87: 1846-1851.
42. Nisbeth U, Lindh E, Ljunghall S, et al. Increased fracture rate in diabetes mellitus and females after renal transplantation. Transplantation 1999; 67: 1218-1222.
43. O'Shaughnessy EA, Dahl DC, Smith CL, et al. Risk factors for fractures in kidney transplantation. Transplantation 2002; 74: 362-366.
44. Palmer SC, Strippoli GF, McGregor DO., Interventions for preventing bone disease in kidney transplant recipients: A systematic review of randomized controlled trials. Am J Kidney Dis 2005; 45: 638-649.
45. Vautour LM, Melton LJ 3rd, Clarke BL, et al. Long-term fracture risk following renal transplantation: A population-based study. Osteoporos Int 2004; 15: 160-167.
46. Cruz DN, Brickel HM, Wysolmerski JJ, et al. Treatment of osteoporosis and osteopenia in long-term renal transplant patients with alendronate. Am J Transplant 2002; 2: 62-67.
47. Heaf J, Tvedegaard E, Kanstrup IL, et al. Bone loss after renal transplantation: Role of hyperparathyroidism, acidosis, cyclosporine and systemic disease. Clin Transplant 2000; 14: 457-463.
48. Setterberg L, Sandberg J, Elinder CG, et al. Bone demineralization after renal transplantation: Contribution of secondary hyperparathyroidism manifested by hypercalcaemia. Nephrol Dial Transplant 1996; 11: 1825-1828.
49. Ghanekar H, Welch BJ, Moe OW, et al. Post-renal transplantation hypophosphatemia: A review and novel insights. Curr Opin Nephrol Hypertens 2006; 15: 97-104.
50. Quinn SJ, Thomsen AR, Pang JL, et al. Interactions between calcium and phosphorus in the regulation of the production of fibroblast growth factor 23 in vivo. Am J Physiol Endocrinol Metab 2013; 304: E310-E320.
51. Rodriguez-Ortiz ME, Lopez I, Munoz-Castaneda JR, et al. Calcium deficiency reduces circulating levels of FGF23. J Am Soc Nephrol 2012; 23: 1190-1197.
52. Wolf M, Molnar MZ, Amaral AP, et al. Elevated fibroblast growth factor 23 is a risk factor for kidney transplant loss and mortality. J Am Soc Nephrol 2011; 22: 956-966.
53. Falck P, Vethe NT, Asberg A, et al. Cinacalcet's effect on the pharmacokinetics of tacrolimus, cyclosporine and mycophenolate in renal transplant recipients. Nephrol Dial Transplant 2008; 23: 1048-1053.
54. EVOLVE Trial Investigators, Chertow GM, Block GA, et al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med 2012; 367: 2482-2494.
55. Evenepoel P, Claes K, Kuypers DR, et al. Parathyroidectomy after successful kidney transplantation: A single centre study. Nephrol Dial Transplant 2007; 22: 1730-1737.
56. Borchhardt KA, Diarra D, Sulzbacher I, et al. Cinacalcet decreases bone formation rate in hypercalcemic hyperparathyroidism after kidney transplantation. Am J Nephrol 2010; 31: 482-489.