The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
Nankivell's formula for calculated GFR is shown below: GFR \[mL/min\] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit \[kg\], H is height at specific visit \[m\], C is the serum concentration of creatinine \[mmol/L\], and UREA is the serum concentration of urea \[mmol/L\]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441\*BUN. If a GFR value from Nankivell formula was less than 10 \[mL/min\], then the value was assigned as 10 \[mL/min\].
Time frame: At Month 3 and Month 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.
Time frame: Month 12
Serum Creatinine at Month 6 and 12
serum creatinine summarized by mean and standard deviation
Time frame: 6 month and 12 months
Calculated Creatinine Clearance at 6 Month and 12 Month
Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl\[mL/min\]) is shown below: CrCl\[mL/min\] = (140 - A) \* W / (72 \* C) \* R. Where A is age at sample date \[years\], W is body weight at specific visit \[kg\], C is the serum concentration of creatinine \[mg/dL\], R = 1 if the patient is male and = 0.85 if female.
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Time frame: 6 month and 12 months