The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Novartis
Basel, Switzerland
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
Pharmacokinetics (PK)
Count of CD4 and CD8 positive lymphocytes
Metabolic control: lipids, glycaemic control, proteinuria, enzymes
Ultrasound ejection fraction
Major adverse cardiovascular events
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