Once-a-Day Administration of CNIs, mTOR and MMF Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study
Surgery - Renal Transplant Unit, Catholic University of the Sacred Heart, Rome, Italy.
Meeting: 2015 American Transplant Congress
Abstract number: D120
Keywords: Immunosuppression, Kidney transplantation
Session Information
Session Name: Poster Session D: Kidney Immunosuppression: Drug Minimization
Session Type: Poster Session
Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Introduction. The half-lives of Tacrolimus, Everolimus, Cyclosporine and Mofetil Micofenolate (MMF) are respectively: 43, 30, 27 and 18 hours. Once-daily dosing of these drugs is therefore possible. Aim of this pilot, prospective, randomized clinical study was to evaluate safety and efficacy of once-daily administration of CNIs, MMF and Everolimus in renal transplant patients (KTx) on maintenance therapy.
Methods. Seventy-one KTx patients were randomized to once-daily maintenance immunosuppressive regimen based on Tacrolimus + MMF + Steroids (33 KTx: TAC+ MMF); Tacrolimus + Everolimus + Steroids (22 KTx: TAC + EVE); Everolimus + Cyclosporine + Steroids (16 KTx: CSA + EVE). All subjects also received induction therapy with a combination of Thymoglobuline and Basiliximab.
Results. All patients completed 1-year follow-up. Patients and graft survival were not significantly different. Renal function was similar in all groups of patients, Acute rejection was higher in the CsA group, exposure to tacrolimus was significantly lower in the group receiving everolimus respect to MMF. No evidence of major non-compliance was evidenced. Data are detailed below
| 1year | TAC + MMF (33) | TAC + EVE (22) | CSA + EVE (16) | p |
|---|---|---|---|---|
| Patients Survival (%) | 100 | 96 | 100 | ns |
| Graft Survival (%) | 94 | 96 | 100 | ns |
| aMDRD (ml/min) | 54 ± 21 | 53 ± 21 | 58 ± 21 | ns |
| Acute Rejection (%) | 12 | 0 | 31 | < 0.01 |
| Drop-out (%) | 6 | 0 | 56 | < 0.01 |
| TACROLIMUS through blood levels (ng/ml) | 6.3 ± 1.5 | 3.6 ± 1.9 | < 0.01 | |
| EVEROLIMUS through blood levels (ng/ml) | 4.3 ± 1.5 | 4.6 ± 0.9 | ns | |
| CYCLOSPORINE (ng/ml) | 373 ± 245 |
Conclusions. Our data support the safety of once-daily dosing of Tacrolimus, Everolimus, Cyclosporine and MMF and the greater efficacy of the combination of Tacrolimus + MMF or Tacrolimus + Everolimus as compared to the combination Cyclosporine + Everolimus
To cite this abstract in AMA style:
Spagnoletti G, Salerno M, Favi E, Pedroso J, Romagnoli J, Citterio F. Once-a-Day Administration of CNIs, mTOR and MMF Is Safe in De Novo Renal Transplant Recipients: 1-Year Results of a Pilot Study [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/once-a-day-administration-of-cnis-mtor-and-mmf-is-safe-in-de-novo-renal-transplant-recipients-1-year-results-of-a-pilot-study/. Accessed May 18, 2025.« Back to 2015 American Transplant Congress