The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
383
Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.
Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.
Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Coppito, AQ, Italy
Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
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
Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
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
Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario
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
Patient Survival Rate: Percentage of Deaths - Worst-case Scenario
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.
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Steroids were administered according to local clinical practice.
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Cagliari, CA, Italy
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
...and 12 more locations
Time frame: 3 Months, 12 months
Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario
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
Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario
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
Percentage of Participants With BPAR - Worst-case Scenario
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
Percentage of Participants With Delayed Graft Function (DGF) -
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
Duration of DGF
The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.
Time frame: 3 months
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT
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
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT
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
Change From Baseline in Serum Creatinine - ITT
Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
Time frame: baseline, 3 months
Change From Baseline in Serum Creatinine - Modified ITT
Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
Time frame: baseline, 12 months
Percentage of Participants With Proteinuria
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
Percentage of Participants With Acute Rejection (AR)
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
Percentage of Participants With a New Onset of Malignancy
The percentage of participants with a new onset of malignancy was assessed.
Time frame: 12 months
Percentage of Participants With a New Onset of Diabetes
The percentage of participants with a new onset of diabetes was assessed.
Time frame: 12 months