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

• Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. [ Time Frame: at 6 Month post-transplantation ] [ Designated as safety issue: No ]

  The primary efficacy variable was the "primary failure endpoint" at 6 months defined as the occurrence of one or more of the following events within the first 6 months:

  • delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
  • efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
  • wound healing disorder related to initial transplant surgery
• Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. [ Time Frame: at 12 Month post-transplantation ] [ Designated as safety issue: No ]

  The primary efficacy variable was the "primary failure endpoint" at 12 months defined as the occurrence of one or more of the following events within the first 12 months:

  • delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation
  • efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)
  • wound healing disorder related to initial transplant surgery
• Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  The number of patients who underwent any dialysis within the 12-month treatment period.
• Duration of Dialysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  The mean duration in days of any dialysis session that occurred within the 12 month treatment period.
• Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
  A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.

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.

• Active Comparator: Immediate Everolimus
  Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
  Intervention: Drug: Everolimus (RAD001)
• Experimental: Delayed Everolimus
  Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
  Intervention: Drug: Everolimus (RAD001)

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.