Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

Inclusion Criteria:

• Recipients of cadaveric kidney transplants

• Patients at risk of DGF defined as one or more of the following:

  • Donor age > 55 years
  • Cold ischemic time (CIT) ≥ 24 hours but < 40 hours
  • Second or subsequent renal transplantation

Exclusion Criteria:

• Patients who have received an investigational drug within 4 weeks of baseline period
• Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
• Patients with body mass index (BMI) > 32 kg/m2

Other protocol-defined exclusion criteria may apply.