Conversion from everolimus with low-exposure cyclosporine to everolimus with mycophenolate sodium maintenance therapy in kidney transplant recipients: A randomized, open-label multicenter study

Annals of Transplantation

Volumn 17, Issue 1, 2012, Pages 58-67

  Albano, Laetitia ^a   Alamartine, Eric ^b   Toupance, Olivier ^c   Moulin, Bruno ^d   Merville, Pierre ^e   Rerolle, Jean Philippe ^f   Tetaz, Rachel ^g   Moal, Marie Christine ^h   Kamar, Nassim ⁱ   Legendre, Christophe ^j   Quéré, Stéphane ^k   Giambattista, Fabienne Di ^k   Terpereau, Arara ^k   Dantal, Jacques ^l  

^a PASTEUR HOSPITAL   (France)

^b University Hospital North   (France)

^c HÔPITAL MAISON BLANCHE   (France)

^d HÔPITAL CIVIL   (France)

^e HÔPITAL PELLEGRIN   (France)

^f DUPUYTREN UNIVERSITY HOSPITAL   (France)

^g HÔPITAL MICHALLON   (France)

^h SERVICE DE RHUMATOLOGIE   (France)

ⁱ CHU RANGUEIL   (France)

^j UNIVERSITÉ PARIS DESCARTES   (France)

^k NOVARTIS PHARMA K K   (Japan)

^l NANTES UNIVERSITY HOSPITAL   (France)

more..

Author keywords

Calcineurin inhibitor; Conversion; EC MPS; Everolimus; Mycophenolic acid; Myfortic

Indexed keywords

CORTICOSTEROID; CREATININE; CYCLOSPORIN; EVEROLIMUS; MYCOPHENOLIC ACID;

ACUTE GRAFT REJECTION; ACUTE KIDNEY FAILURE; ANEMIA; APHTHOUS STOMATITIS; ARTICLE; BIOPSY; BRONCHITIS; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEHYDRATION; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG EXPOSURE; DRUG FEVER; DRUG SAFETY; DYSLIPIDEMIA; FALLING; FEMALE; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; HUMAN; HUMAN TISSUE; HYPERTENSION; KIDNEY TRANSPLANTATION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERIPHERAL EDEMA; PROTEINURIA; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THORAX PAIN; URINARY TRACT INFECTION;

EID: 84859396142     PISSN: 14259524     EISSN: None     Source Type: Journal    
DOI: 10.12659/aot.882637     Document Type: Article

References (40)

1. Schuler W, Sedrani R, Cottens S et al: SDZ RAD, a new rapamycin derivative: pharmacologic properties in vitro and in vivo. Transplantation, 1997; 64: 36-42
2. Schuurman J-J, Cottens S, Fuchs S et al: SDZ RAD, a new rapamycin derivative: synergism with cyclosporine. Transplantation, 1997; 64: 32-35
3. Nashan B, Curtis J, Ponticelli C et al., 156 Study Group: Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: a three-year Phase II, randomized, multicenter, open-label study. Transplantation, 2004; 78: 1332-40
4. Lutz J, Zou H, Liu S et al: Apoptosis and treatment of chronic allograft nephropathy with everolimus. Transplantation, 2003; 76: 508-15
5. Koch M, Mengel M, Poehnert D, Nashan B: Effects of everolimus on cellular and humoral immune processes leading to chronic allograft nephropathy in a rat model with sensitized recipients. Transplantation, 2007; 83: 498-505
6. Lebranchu Y, Thierry A, Toupance O et al: Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: CONCEPT study. Am J Transplant, 2009; 9: 1115-23
7. Guba M, Pratschke J, Hugo C et al: SMARTStudy Group. Renal function, efficacy, and safety of sirolimus and mycophenolate mofetil after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients: one-year analysis of a randomized multicenter trial. Transplantation, 2010; 90: 175-83
8. Morales JM, Grinyo JM, Campistol JM et al: Improved renal function, with similar proteinuria, after two years of early tacrolimus withdrawal from a regimen of sirolimus plus tacrolimus. Transplantation, 2008; 86: 620-22
9. Budde K, Becker T, Arns W et al: Everolimusbased, calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: an open-label, randomised, controlled trial. Lancet, 2011; 377: 837-47
10. Holdaas H, Bentdal O, Pfeffer P et al: Early, abrupt conversion of de novo renal transplant patients from cyclosporine to everolimus: results of a pilot study. Clin Transplant, 2008; 22: 366-71
11. Bemelman FJ, de Maar EF, Press RR et al: Minimization of maintenance immunosuppression early after renal transplantation: an interim analysis. Transplantation, 2009; 88: 421-28
12. Nankivell BJ, Borrows RJ, Fung CL et al: Calcineurin inhibitor nephrotoxicity: longitudinal assessment by protocol histology. Transplantation, 2004; 78: 557-65
13. Weir MR, Mulgaonkar S, Chan L et al: Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial. Kidney Int, 2011; 79: 897-907
14. Schena FP, Pascoe MD, Alberu J et al: Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation, 2009; 87: 233-42
15. Flechner SM, Kurian SM, Solez K et al: De novo kidney transplantation without use of calcineurin inhibitors preserves renal structure and function at two years. Am J Transplant, 2004; 4: 1776-85
16. Groth CG, Backman L, Morales JM et al: Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporin. Sirolimus European Renal Transplant Study Group. Transplantation, 1999; 67: 1036-42
17. Kreis H, Cisterne JM, Land W et al: Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation, 2000; 69: 1252-60
18. Buchler M, Caillard S, Barbier S et al: Sirolimus versus cyclosporine in kidney recipients receiving thymoglobulin, mycophenolate mofetil and a 6-month course of steroids. Am J Transplant, 2007; 7: 2522-31
19. Dean PG, Grande JP, Sethi S et al: Kidney transplant histology after one year of continuous therapy with sirolimus compared to tacrolimus. Transplantation, 2008; 85: 1212-15
20. Webster AC, Lee VWS, Chapman JR et al: Target of rapamycin inhibitors (sirolimus and everolimus) for primary immunosuppression of kidney transplant recipients: a systematic review and meta-analysis of randomized trials. Transplantation, 2006; 81: 1234-48
21. Srinivas TR, Schold JD, Guerra G et al: Mycophenolate mofetil/sirolimus compared to other common immunosuppressive regimens in kidney transplantation. Am J Transplant, 2007; 7: 586-94
22. Ekberg H, Tedesco-Silva H, Demirbas A et al., ELITE-Symphony Study: Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med, 2007; 357: 256-75
23. Durrbach A, Rostaing L, Tricot L et al: Prospective comparison of the use of sirolimus and cyclosporine in recipients of a kidney from an expanded criteria donor. Transplantation, 2008; 85: 486-90
24. Larson TS, Dean PG, Stegall MD et al: Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant, 2006; 6: 514-22
25. Tedesco Silva H Jr, Cibrik D, Johnston T et al: Everolimus plus reduced-exposure CsA versus mycophenolic acid plus standard-exposure CsA in renal-transplant recipients. Am J Transplant, 2010; 10: 1401-13
26. Ciancio G, Burke GW, Gaynor JJ et al: A randomized long-term trial of tacrolimus and sirolimus versus tacrolimus and mycophenolate mofetil versus cyclosporine (NEORAL) and sirolimus in renal transplantation. I. Drug interactions and rejection at one year. Transplantation, 2004; 77: 244-51
27. Van Gurp E, Bustamante J, Franco A et al: Comparable renal function at 6 months with tacrolimus combined with fixed-dose sirolimus or MMF: results of a randomized multicenter trial in renal transplantation. J Transplant, 2010; 2010.pii 731426
28. Stallone G, Di Paolo S, Schena A et al: Early withdrawal of cyclosporine A improves 1-year kidney graft structure and function in sirolimus- treated patients. Transplantation, 2003; 75: 998-1003
29. Baboolal K: A phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients. Transplantation, 2003; 75: 1404-8
30. Grinyo JM, Paul J, Novoa P et al: Better renal function in renal-transplant recipients treated with everolimus plus CsA elimination compared with CsA reduction. Transpl Int, 2009; 22(S2): 183
31. Albano L, Berthoux F, Moal MC et al: Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus. Transplantation, 2009; 88: 69-76
32. Dantal J, Berthoux F, Moal MC et al: Efficacy and safety of de novo or early everolimus with low cyclosporine in deceased-donor kidney transplant recipients at specified risk of delayed graft function: 12-month results of a randomized, multicenter trial. Transplant Int, 2010; 23: 1084-93
33. Poggio ED, Wang X, Weinstein DM et al: Assessing glomerular filtration rate by estimation equations in kidney transplant recipients. Am J Transplant, 2006; 6: 100-8
34. Nankivell BJ, Borrows RJ, Fung CL et al: Evolution and pathophysiology of renal transplant glomerulosclerosis. Transplantation, 2004; 78: 461-68
35. Holdaas H, Rostaing L, Seron D et al: Conversion of long-term kidney transplant recipients from calcineurin inhibitor therapy to everolimus: A randomized, multicenter, 24-month study. Transplantation, 2011; 92: 410-18
36. Masetti M, Montalti R, Rompianesi G et al: Early withdrawal of calcineurin inhibitors and everolimus monotherapy in de novo liver transplant recipients preserves renal function. Am J Transplant, 2010; 10: 2252-62
37. De Simone P, Metselaar HJ, Fischer L et al: Conversion from a calcineurin inhibitor to everolimus therapy in maintenance liver transplant recipients: a prospective, randomized, multicenter trial. Liver Transpl, 2009; 15: 1262-69
38. Gude E, Gullestad L, Arora S et al: Benefit of early conversion from CNI-based to everolimusbased immunosuppression in heart transplantation. J Heart Lung Transplant, 2010; 29: 641-47
39. Nankivell BJ, Borrows RJ, Fung CL-S et al: The natural history of chronic allograft nephropathy. N Engl J Med, 2003; 349: 2326-33
40. Rostaing L, Kamar N: mTOR inhibitor/proliferation signal inhibitors: entering or leaving the field? J Nephrol, 2010; 23: 133-42