12-month safety and efficacy of everolimus with reduced exposure cyclosporine in de novo renal transplant recipients

Transpl Int. 2007 Jan;20(1):27-36. doi: 10.1111/j.1432-2277.2006.00414.x.


The proliferation signal inhibitor everolimus (Certican), has demonstrated efficacy with full-dose cyclosporine (CsA) (Neoral). Two multicenter randomized controlled studies were performed to compare 12-month efficacy and safety of everolimus 1.5 and 3.0 mg/day with reduced-dose CsA. Study 1 enrolled 237 de novo renal allograft recipients, randomizing 222 nonblack patients to either everolimus 1.5 or 3.0 mg/day, with the Neoral) dose guided by C(2) (monitoring of CsA concentration 2 h after dosing). Study 2 had a similar protocol, with basiliximab included, enrolling 256 recipients and randomizing 243 nonblack patients. In Study 1, there was a lower incidence of acute rejection in nonblack patients on 3 mg/day (16.4%) compared with 1.5 mg/day (25.9%), P = 0.08. In Study 2, the inclusion of basiliximab lowered the overall incidence of acute rejection; 14.3% of nonblack patients (3 mg/day) and 13.6% of nonblack patients (1.5 mg/day) had acute rejection by 12 months (P =0.891). Renal function was preserved throughout the study, with no differences observed between groups within studies. Everolimus was well tolerated with no significant differences between doses. Everolimus, in combination with reduced-dose Neoral), demonstrated efficacy and was well tolerated. Basiliximab allows for utilization of lower doses of everolimus with reduced dosing of Neoral).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cyclosporine / therapeutic use*
  • Dose-Response Relationship, Drug
  • Everolimus
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Kidney Function Tests
  • Kidney Transplantation / immunology*
  • Male
  • Middle Aged
  • Reproducibility of Results
  • Safety
  • Sample Size
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use
  • Time Factors
  • Treatment Outcome


  • Immunosuppressive Agents
  • Cyclosporine
  • Everolimus
  • Sirolimus