Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS

Abstract EN

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.