Everolimus in de Novo Kidney Transplant Recipients

The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.

Time frame: 3 months

Population: The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.

Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement.

Time frame: baseline, 3 Months

Population: Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated.

Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement.

Time frame: baseline, 12 months

Population: Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.

Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.

Time frame: baseline, 3 months

Population: Participants from the ITT, who had both baseline and the post-baseline measurement for a given post-baseline time point, were included in the analysis for that post-baseline time point. The ITT population included all randomized participants who were treated.

Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.

Time frame: baseline, 12 months

Population: Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.

The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.

Time frame: 3 months

Population: Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated.

The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.

Time frame: 3 months, 12 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.

Time frame: 3 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.

Time frame: 3 Months, 12 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.

Time frame: 3 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

AR was defined as an episode of increased serum creatinine \>30% that was clinically diagnosed as an acute rejection but was not biopsy proven.

Time frame: 12 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

The percentage of participants with a new onset of diabetes was assessed.

Time frame: 12 months

Population: Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.

The percentage of participants with a new onset of malignancy was assessed.

Time frame: 12 months

Population: Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.

A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.

Time frame: 3 Months, 12 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.

Time frame: 3 Months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.

The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.

Time frame: 12 months

Population: The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.

Incidence of proteinuria (\>1,000 mg/day in urine collected in 24 hours or \> 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.

Time frame: 3 months

Population: The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.