Aim: To follow up on renal function (GFR) at month (Mo) 48 after kidney transplantation (Tx) in patients (pts) on immunosuppressive regimen with different calcineurin inhibitor (CNI) exposures.

Methods: 802 pts were included in this prospective, open-label, randomized multi-center study. After induction with basiliximab all pts received cyclosporine A (CsA), enteric-coated mycophenolate sodium (EC-MPS) and steroids. 3Mo post Tx 499 pts were randomized 1:1:1 to either i) continue standard (STD) CsA(100-180ng/ml) with EC-MPS (n=166), ii) convert to a CNI-free regimen with everolimus (EVR;5-10ng/ml) +EC-MPS (n=171) or iii) convert to CNI-low regimen CsA (50-75ng/ml) with EVR(3-8ng/ml) (n=162).

Results: Here data from 48Mo observational follow-up are presented: GFR (Nankivell, ITT) was similar at randomization 3Mo post Tx and had significantly improved at Mo12 by +5.6mL/min (95% CI:[+2.9;+8.3]; p<0.001) and remained significantly improved by +6.8mL/min in favor of CNI-free regimen at Mo48(p=0.02). 54% of CNI-free, 36% of CNI-low and 44% of STD pts had an improvement in GFR at Mo48 (p=0.09 CNI-free vs STD). All 3 groups had similar rejection rate since randomization (13%STD, 16%CNI-free, 16%CNI-low) and overall comparable safety profile. Median trough levels at Mo48: CsA 92ng/ml in STD, 80ng/ml in CNI-low pts and EVR 5.1ng/ml in CNI-free, 5.0 ng/ml in CNI-low pts.

Conclusion: CNI-free as well as reduced CNI in combination with EVR are both efficacious and safe regimen. CNI-low group had higher CsA levels than anticipated. The fact that CNI reduction was not fully accomplished might have prevented GFR differences compared to STD. However, CNI-free regimen was associated with better GFR maintained for 4 years post Tx. The results of this large trial confirm previous reports of improved GFR after CsA withdrawal with EVR in combination with EC-MPS.

« Back to 2015 American Transplant Congress