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:: Volume 32, Issue 1 (4-2024) ::
Journal of Ilam University of Medical Sciences 2024, 32(1): 13-25 Back to browse issues page
Comparison between the efficacy and safety of de novo Everolimus plus low dose Cyclosporin protocol and standard regimen (Cyclosporine plus Cellcept) in renal transplant patients
Nooshin Dalili * 1, Fatemeh Pour-rezagholi2 , Maryam Mousavi2 , Morvarid Alinezhad2 , Reza Asadzadeh3 , Sadra Ashrafi4 , Shiva Samavat2
1- Dept of Nephrology, Labbafinezhad Medical Center, Shahid Beheshti University of Medical Sciences , nooshindalili4@gmail.com
2- Dept of Nephrology, Labbafinezhad Medical Center, Shahid Beheshti University of Medical Sciences
3- Dept of Nephrology, Faculty of Medicine, Ilam University of Medical Sciences, Iran
4- Shahid Beheshti Medical School, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Abstract:   (295 Views)
Introduction:  Although many years have passed since the first successful kidney transplantation, there are still numerous questions about the best immunosuppression regimen for these patients. Various studies have demonstrated that long-term use of calcineurin inhibitors can be associated with reversible changes accompanied by irreversible damage to all kidney compartments, leading to both acute and chronic nephrotoxicity. Nowadays, the goal is to optimize available immunosuppressive regimens and reduce the calcineurin inhibitor dose as much as possible while protecting the transplanted kidney from rejection. The present study aimed to compare renal function, Cytomegalovirus infection, BK nephropathy rate, and biopsy-proven acute rejection in two regimens: an everolimus plus reduced calcineurin inhibitor-based regimen versus a standard dose calcineurin-inhibitor protocol with mycophenolic acid.
Material & Methods: This was a 12-month, open-label, randomized study of 60 Iranian kidney transplant recipients (aged 18-65). The first group received cyclosporine at a dose of 3.5 mg per kilogram of body weight together with everolimus 0.75 mg twice a day, along with corticosteroids, and the second group received cyclosporine at a dose of 6 mg per kilogram of body weight along with mycophenolic acid 1 gram twice a day, along with corticosteroids. All patients received thymoglobulin induction.
Results: Renal function based on glomerular filtration rate in two groups 6 and 12 months after transplantation did not show a statistically significant difference. Furthermore, there was no difference between the two groups regarding the incidence of transplant rejection, while the rate of cytomegalovirus and BK infection within the first year after transplantation was lower in the group that received everolimus.
Discussion & Conclusion: The present study suggested non-inferiority and overall safety of de novo everolimus-based regimen in Iranian kidney transplant recipients with preserved renal function and significantly lower viral infections without increasing the risk of acute rejection in the first post-operation year, which could impact long-term outcomes and offer renal benefits versus the standard calcineurin-inhibitor based regimens.
Keywords: CMV infection, Kidney transplantation, Rejection
Full-Text [PDF 512 kb]   (134 Downloads)    
Type of Study: Applicable | Subject: Internal operations( nursing )
Received: 2023/10/10 | Accepted: 2023/10/31 | Published: 2024/05/4
References
1. Sharif A, Shabir S, Chand S, Cockwell P, Ball S, Borrows R. Meta-analysis of calcineurin-inhibitor-sparing regimens in kidney transplantation. J Am Soc Nephrol 2011;22:2107-18. doi: 10.1681/ASN.2010111160.
2. Dantal J. Everolimus: preventing organ rejection in adult kidney transplant recipients. Expert Opin Pharmacother 2012; 13: 767-78. doi:10.1517/14656566.2012.662955.
3. Gurk-Turner C, Manitpisitkul W, Cooper M. A comprehensive review of everolimus clinical reports: a new mammalian target of rapamycin inhibitor. Transplantation 2012;94:659-68. doi: 10.1097/TP.0b013e31825b411c.
4. Pascual J, Boletis IN, Campistol JM. Everolimus (Certican) in renal transplantation: a review of clinical trial data, current usage, and future directions. Transplant Rev 2006;20:1-18.doi: 10.1016/j.trre.2005.10.005.
5. Schuurman HJ, Cottens S, Fuchs S, Joergensen J, Meerloo T, Sedrani R, et al. SDZ RAD, a new rapamycin derivative: synergism with cyclosporine. Transplantation 1997;64:32-5. doi: 10.1097/00007890-199707150-00007.
6. Euvrard S, Boissonnat P, Roussoulières A, Kanitakis J, Decullier E, Claudy A, et al. Effect of everolimus on skin cancers in calcineurin inhihitor‐treated heart transplant recipients. Transpl Int 2010;23(8):855-7. doi: 10.1111/j.1432-2277.2009.01010.x.
7. Campistol JM, Eris J, Oberbauer R, Friend P, Hutchison B, Morales JM, et al. Sirolimus therapy after early cyclosporine withdrawal reduces the risk for cancer in adult renal transplantation. J Am Soc Nephrol 2006;17:581-9. doi: 10.1681/ASN.2005090993.
8. Gutiérrez-Dalmau Á, Campistol JM. The role of proliferation signal inhibitors in post-transplant malignancies. Nephrol Dial Transplant 2007;22 Suppl 1:i11-6. doi: 10.1093/ndt/gfm084.
9. Tarantino G, Capone D. Inhibition of the mTOR pathway: a possible protective role in coronary artery disease. Ann Med 2013; 45: 348-56. doi:10.3109/07853890.2013.770333.
10. Paoletti E, Amidone M, Cassottana P, Gherzi M, Marsano L, Cannella G. Effect of sirolimus on left ventricular hypertrophy in kidney transplant recipients: a 1-year nonrandomized controlled trial. Am J Kidney Dis 2008;52:324-30. doi: 10.1053/j.ajkd.2008.04.018.
11. Zeier M, Van Der Giet M. Calcineurin inhibitor sparing regimens using m‐target of rapamycin inhibitors: an opportunity to improve cardiovascular risk following kidney transplantation? Transpl Int 2011;24:30-42. doi: 10.1111/j.1432-2277.2010.01140.x.
12. Brennan DC, Legendre C, Patel D, Mange K, Wiland A, McCague K, et al. Cytomegalovirus incidence between everolimus versus mycophenolate in de novo renal transplants: pooled analysis of three clinical trials. Am J Transplant 2011;11:2453-62. doi: 10.1111/j.1600-6143.2011.03674.x.
13. Durrbach A, Rostaing L, Tricot L, Ouali N, Wolf P, Pouteil-Noble C, 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. doi: 10.1097/TP.0b013e318160d3c9.
14. Ekberg H, Tedesco-Silva H, Demirbas A, Vítko Š, Nashan B, Gürkan A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007;357:2562-75. doi: 10.1056/NEJMoa067411.
15. Nashan B, Curtis J, Ponticelli C, Mourad G, Jaffe J, Haas T, et al. 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. doi: 10.1097/01.tp.0000140486.97461.49.
16. Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, et al. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation 2008;85:821-6. doi: 10.1097/TP.0b013e318166927b.
17. Langer RM, Hene R, Vitko S, Christiaans M, Tedesco‐Silva H, Ciechanowski K, et al. Everolimus plus early tacrolimus minimization: a phase III, randomized, open‐label, multicentre trial in renal transplantation. Transpl Int 2012;25:592-602. doi: 10.1111/j.1432-2277.2012.01465.x.
18. Vitko S, Tedesco H, Eris J, Pascual J, Whelchel J, Magee JC, et al. Everolimus with Optimized Cyclosporine Dosing in Renal Transplant Recipients: 6‐Month Safety and Efficacy Results of Two Randomized Studies. Am J Transplant 2004;4:626-35. doi: 10.1111/j.1600-6143.2004.00389.x.
19. Qazi Y, Shaffer D, Kaplan B, et al. Efficacy and safety of everolimus with low-dose tacrolimus in de novo renal transplant recipients; 12-month randomized study. Am J Transplant 2017;17:1358-69. doi: 10.1111/ajt.14090.
20. Witzke O, Sommerer C, Arns W. Everolimus immunosuppression in kidney transplantation: What is the optimal strategy? Transplant Rev (Orlando) 2016;30:3-12. doi: 10.1016/j.trre.2015.09.001.
21. Bertoni E, Larti A, Rosso G, Zanazzi M, Di Maria L, Salvadori M. Good outcomes with cyclosporine very low exposure with everolimus high exposure in renal transplant patients. J Nephrol 2011;24:613-8. doi: 10.5301/JN.2011.6247.
22. Tedesco-Silva Jr H, Cibrik D, Johnston T, Lackova E, Mange K, Panis C, 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. doi: 10.1111/j.1600-6143.2010.03129.x.
23. Albano L, Berthoux F, Moal MC, Rostaing L, Legendre C, Genin R, 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. doi: 10.1097/TP.0b013e3181aa7d87.
24. Cibrik D, Silva Jr HT, Vathsala A, Lackova E, Cornu-Artis C, Walker RG, et al. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation 2013;95:933-42. doi: 10.1097/TP.0b013e3182848e03.
25. Shihab FS, Cibrik D, Chan L, Kim YS, Carmellini M, Walker R, et al. Association of clinical events with verolimus exposure in kidney transplant patients receiving reduced cyclosporine. Clin Transplant 2013;27:217-26. doi: 10.1111/ctr.12045.
26. Nankivell BJ, Borrows RJ, Fung CL-S, O'Connell PJ, Chapman JR, Allen RD. Calcineurin inhibitor nephrotoxicity: longitudinal assessment by protocol histology. Transplantation 2004; 78:557-65. doi: 10.1097/01.tp.0000128636.70499.6e.
27. Salvadori M, Scolari MP, Bertoni E, Citterio F, Rigotti P, Cossu M, et al. Everolimus with very low-exposure cyclosporine an in de novo kidney transplantation: a multicenter, randomized, controlled trial. Transplantation 2009;88:1194-202. doi: 10.1097/TP.0b013e3181bb43ec.
28. Moscarelli L, Caroti L, Antognoli G, Zanazzi M, Di Maria L, Carta P, et al. Everolimus leads to a lower risk of BKV viremia than mycophenolic acid in de novo renal transplantation patients: a single-center experience. Clin Transplant 2013;27:546-54. doi: 10.1111/ctr.12151.
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Dalili N, Pour-rezagholi F, Mousavi M, Alinezhad M, Asadzadeh R, Ashrafi S et al . Comparison between the efficacy and safety of de novo Everolimus plus low dose Cyclosporin protocol and standard regimen (Cyclosporine plus Cellcept) in renal transplant patients. J. Ilam Uni. Med. Sci. 2024; 32 (1) :13-25
URL: http://sjimu.medilam.ac.ir/article-1-8121-en.html


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Volume 32, Issue 1 (4-2024) Back to browse issues page
مجله دانشگاه علوم پزشکی ایلام Journal of Ilam University of Medical Sciences
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