Although CI have proven efficacy in kidney transplantation worldwide, they are drugs with nephrotoxic potential and may contribute to chronic renal allograft nephropathy. As a result, there is an interest in developing regimens that involve CI withdrawal or minimization.

This study acessed whether everolimus, introduced on the 16th post-transplant week in place of tacrolimus and combined with mycophenolate acid and prednisone reduced the incidence of chronic allograft nephropathy and presented similar renal function at one year measured by creatinine levels compared to a control group mantained on tacrolimus+mycophenolate acid + prednisone.

The study population was composed of 28 kidney transplant patients considered of low immunological risk and defined as follows: recipients of a first kidney transplant (living or deceased donor), with PRA <10% and no pre-transplant DSA. Additionally, the patients had to present stable creatinine levels and absence of immunological events during the first three months post-renal transplant.

In this study, 15 patients were randomized to the tacrolimus arm and 13 to recieve everolimus. At the end of 12 months of transplantation, a protocol allograft biopsy was performed.

At one year, creatinine levels were similar in both groups (1.19mg/dL in the everolimus arm vs. 1.44mg/dL in the tacrolimus arm; p = 0.133).

The graft rejection rate in either arm was exactly the same: 7.1% (p = 0.644). Regarding graft loss, we did not observe any loss in the everolimus group. In the tacrolimus group, two patients (7.1%) lost the kidney graft, a difference that was not statistically significant (p = 0.78). There were no deaths in either group during the study.

Three patients in the tacrolimus arm had considerable interstitial fibrosis and tubular atrophy (20-40%) in biopsy samples. In the everolimus arm, only one patient presented similar findings. In the tacrolimus arm, biopsy disclosed in one patient signs of calcineurin toxicity (9.1%).

In low immunological risk patients with initial triple immunosuppression, replacing tacrolimus for everolimus on the 16th week resulted in a similar kidney function and rejection rates in a one year follow-up.

CITATION INFORMATION: Giordano L, Lasmar M, Vianna H, Lasmar E. Single-Center, Prospective, Open Label Pilot Study to Investigate the Effectiveness of Everolimus Associated with Mycophenolic Acid and Prednisone in Adult Patients Submitted to an Allograft Renal Transplant with Calcineurin Inhibitor Withdrawl on Week 16th. Am J Transplant. 2017;17 (suppl 3).

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