Introduction: Tubular expression of vimentin and cytoplasmic translocation of β-catenin, consistent with epithelial to mesenchymal transition (EMT), may predict IF/TA and thus help identify patients at increased risk for calcineurin inhibitor (CNI)-related nephrotoxicity who could benefit from conversion to the mTOR inhibitor everolimus. Methods: CERTITEM was a prospective, multicenter, randomized, open-label trial of de novo kidney transplant recipients. Key exclusion criteria were (a) at transplant: PRA >20%, positivity for class I or II anti-HLA donor specific antibodies (DSA), cold ischemia time >30h and proteinuria >0.8g/24h (b) at randomization: biopsy-proven acute rejection (BPAR) or subclinical acute rejection on protocol biopsies, DSA-positivity, calculated eGFR (MDRD4) < 30mL/min and proteinuria >0.8g/24h. All patients received CsA with enteric-coated mycophenolic acid (EC-MPS), IL-2RA induction and oral steroids. Patients were stratified by centrally-analyzed EMT status on month 3 protocol biopsy, then randomized from month 4 to continue their current regimen (CsA) or start everolimus (C0 6-10ng/mL) with EC-MPS. EMT+ was defined as ≥10% tubular cells showing de novo expression of vimentin (or translocation of β-catenin if inconclusive) into the cytoplasm (EMT score ≥2). Primary endpoint is progression of centrally-analyzed IF/TA (score increase ≥1) during months 3-12 in patients EMT+ at month 3. Characteristics of randomized patients at month 3 will be described, all patients having received CsA-based therapy to this point. Results: 194 patients were randomized: 75(38.7%) EMT+ (36 everolimus, 39 CsA), 119(61.3%) EMT- (60 everolimus, 59 CsA). Baseline characteristics were similar between the EMT+ and EMT- groups other than a more frequent history of DGF in EMT+ patients (Table). Mean IF/TA score was higher in EMT+ versus EMT- patients overall and within treatment arms (all p< 0.001). On univariate analysis, recipient female gender (p=0.022), DGF (p=0.001), calculated GFR < 50mL/min/1.73m2 (p=0.022) and IF/TA grade at month 3 were associated with EMT+ status at month 3. Multivariate analysis confirmed the associations between female gender (OR 2.67, p=0.009), DGF (OR 4.70, p< 0.001) and IF/TA grade at month 3 (OR 20.93 for grade ≥II versus 0, OR 1.96 for grade ≥II vs I; p< 0.001 overall) and EMT+ status at month 3.Conclusion: These preliminary descriptive results confirm that IF/TA grade at month 3, although very mild, is still significantly higher in EMT+ patients. This study will determine whether conversion from CNI to a CNI-free everolimus regimen 4 months after kidney transplantation inhibits progression of graft fibrogenesis in EMT+ recipients and evaluate the prognostic value of EMT for IF/TA progression.