RenalCandidateOnce-a-Day Administration of Everolimus Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study
Section snippets
Methods
This study was performed on patients who signed an informed consent form, using immunosuppressive protocols approved by our ethical committee. This prospective, consecutive group clinical study enrolled 41 adult male and nonpregnant female patients who underwent primary kidney transplantation from a deceased donor between 2006 and 2009. We excluded recipients with a historical or current peak panel-reactive antibodies > 50%; cold ischemia time > 24 hours; thrombocytopenia (platelets < 75,000/mm3
Results
Forty-one de novo deceased donor kidney transplant recipients were enrolled in the study: 21 patients were allocated to the OD and 20 to the BID group. All patients completed the 1-year observation period.
The demographic characteristics of the two groups of patients were not significantly different at baseline for sex, time on dialysis, cold ischemia time, human leukocyte antigen mismatch, body mass index, dyslipidemia, hypertension, and diabetes mellitus. Age at transplant and donor age were
Discussion
In this prospective clinical study of de novo deceased donor kidney transplant recipients, we showed that once a day administration of everolimus provided excellent patient and graft survival as well as good renal function without an increased incidence of acute rejection episodes and a similar safety profile as twice a day everolimus administration.
Pharmacokinetic studies in the clinical development phase of everolimus already showed the basis for the once a day administration of everolimus.
References (10)
- et al.
A retrospective analysis of immunosuppression compliance, dose reduction and discontinuation in kidney transplant recipients
Am J Transplant
(2007) - et al.
Three-year efficacy and safety results from a study of everolimus versus mycophenolate mofetil in the novo renal transplant patients
Am J Transplant
(2005) - 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) - et al.
Risk factors for cardiovascular events after successful renal transplantation
Transplantation
(2008) - et al.
Rapamycin: clinical results and future opportunities
Transplantation
(2001)
Cited by (6)
Focus on mTOR inhibitors and tacrolimus in renal transplantation: Pharmacokinetics, exposure-response relationships, and clinical outcomes
2014, Transplant ImmunologyCitation Excerpt :EVR has an elimination half-life of approximately 30 h [19]. Prescribing information recommends EVR be administered twice daily (bid) in transplant recipients, mainly because of the CsA/EVR interaction described in the following section; however, preliminary evidence in renal transplant recipients suggests similar efficacy (e.g. patient survival and graft survival, acute rejection episodes) and renal function with once-daily versus twice-daily EVR dosing when given with CNIs [27–29]. The main route of clearance for SRL is also biliary; with 91% of SRL metabolites found in feces and 2.2% in urine [21].
A review on therapeutic drug monitoring of the mTOR class of immunosuppressants: everolimus and sirolimus
2017, Drugs and Therapy PerspectivesSafety and efficacy of two different doses of everolimus in kidney transplantation: A systematic review and meta-analysis
2017, Iranian Journal of Kidney DiseasesTherapeutic drug monitoring of everolimus: A consensus report
2016, Therapeutic Drug MonitoringRash to the mTOR inhibitor everolimus systematic review and meta-analysis
2014, American Journal of Clinical Oncology: Cancer Clinical Trials