title: Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS.
abstract: Information is lacking concerning concomitant administration of enteric-coated mycophenolate sodium with tacrolimus (EC-MPS+Tac) in renal transplant recipients (RTxR). In this 6-month, prospective, open-label, multicenter study, de novo RTxR were randomized (1 : 1) to low-dose (LD) or standard-dose (SD) Tac with basiliximab, EC-MPS 720 mg bid, and steroids. Primary objective was to compare renal function at 6-month posttransplantation. Secondary objectives were to compare the incidences of biopsy-proven acute rejection (BPAR), graft loss and death, and new-onset diabetes mellitus (NODM). 292 patients (LD n = 151, SD n = 141) were included. Mean Tac levels were at the low end of the target range in standard-exposure patients (SD, n = 141) and exceeded target range in low-exposure patients (LD = 151) throughout the study. There was no significant difference in mean glomerular filtration rate (GFR) between treatments (ITT-population: 63.6 versus 61.0 mL/min). Incidence of BPAR was similar (10.6% versus 9.9%). NODM was significantly less frequent in LD Tac (17% versus 31%; P = 0.02); other adverse effects (AEs) were comparable. EC-MPS+Tac (LD/SD) was efficacious and well tolerated with well-preserved renal function. No renal function benefits were demonstrated, possibly related to poor adherence to reduced Tac exposure.
authors.affiliation: Transplant Center, University of Colorado Denver, Aurora, CO 80045, USA.
authors.forename: Laurence
authors.initials: L
authors.lastname: Chan
authors.forename: Amado
authors.initials: A
authors.lastname: Andres
authors.forename: Suphamai
authors.initials: S
authors.lastname: Bunnapradist
authors.forename: Kristene
authors.initials: K
authors.lastname: Gugliuzza
authors.forename: Ravi
authors.initials: R
authors.lastname: Parasuraman
authors.forename: V Ram
authors.initials: VR
authors.lastname: Peddi
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Cassuto
authors.forename: Marquis
authors.initials: M
authors.lastname: Hart