This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)
10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only
0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only
Novartis Investigative Site
Bad Oeynhausen, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hanover, Germany
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.
Time frame: Month 18
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18
Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.
Time frame: Month 6 to Month 9; Month 9 to Month 18
Occurrence of Major Cardiac Events (MACE) From Month 6 to 18
Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting
Time frame: Month 6 to Month 18
Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18
Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)
Time frame: Month 12 and 18
Serum Creatinine at Month 6, 8, 9, 10 12 and 18
Serum Creatinine is an indicator of renal function measured in the blood
Time frame: Month 6, 8, 9, 10 12 and 18
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180 mg or 360 mg tablet dosed 1440-2280 mg per day
250 mg or 500 mg tablets with a dose of 1500-3000 mg per day
according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Münster, Germany
Novartis Investigative Site
Regensburg, Germany
Reciprocal Creatinine Slope Between Month 6 and Month 18
Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.
Time frame: Between Month 6 and Month 18