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

Abstract

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