| Outcome Measures: |
Primary: Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation), Everolimus (RAD001) compared to placebo with respect to the change from baseline in total kidney volume at Month 24., Baseline, Month 24 | Secondary: Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60, Course of calculated GFR (mL/min/1.73 m\^2) at Months 24, 36, 48 and 60, Months 24, 36, 48 and 60|Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR, Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m\^2) = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported., Months 24, 36, 48 and 60|Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24, Baseline, Months 12 and 24|Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit, Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m\^2) = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported., Months 3, 6, 9, 12, 18 and 24
|
| Locations: |
Novartis Investigative Site, Innsbruck, INNSBRUCK, Austria|Novartis Investigative Site, Linz, A-4010, Austria|Novartis Investigative Site, Wien, 1090, Austria|Novartis Investigative Site, Brest, 29200, France|Novartis Investigative Site, Grenoble, 38043, France|Novartis Investigative Site, Nantes Cedex, 44035, France|Novartis Investigative Site, Paris cedex 15, 75015, France|Novartis Investigative Site, Toulouse Cedex 4, 31054, France|Novartis Investigative Site, Berlin, 10117, Germany|Novartis Investigative Site, Berlin, 13353, Germany|Novartis Investigative Site, Erlangen, 91054, Germany|Novartis Investigative Site, Essen, 45147, Germany|Novartis Investigative Site, Frankfurt am Main, 60596, Germany|Novartis Investigative Site, Freiburg, 79106, Germany|Novartis Investigative Site, Hamburg, 20246, Germany|Novartis Investigative Site, Heidelberg, 69120, Germany|Novartis Investigative Site, Homburg, 66421, Germany|Novartis Investigative Site, Kiel, 24105, Germany|Novartis Investigative Site, Koeln, 51109, Germany|Novartis Investigative Site, Leipzig, 04103, Germany|Novartis Investigative Site, Lübeck, 23538, Germany|Novartis Investigative Site, Muenster, 48149, Germany|Novartis Investigative Site, Regensburg, 93053, Germany|Novartis Investigative Site, Würzburg, 97080, Germany
|
