Background: CERTITEM has evaluated the effect of everolimus/calcineurin inhibitors free (CNI free) on fibrosis progression and results have been reported at 12 months (M12). Data at M24 have been collected as part of a 6 year post transplantation observational study (C4Ever), setup to evaluate the impact of CNI free vs. cyclosporin + mycophenolic acid (CsA+MPA) on the incidence of cancer and major cardiovascular events (MACE) in renal transplant recipients (RTx).

Methods: In CERTITEM, patients were randomized into 2 treatment groups at M3: CNI-free and CsA+MPA. Patients who completed the CERTITEM M12 visit were included in C4Ever.

Results: At M24, 141 patients were evaluable (67 in CNI free, 74 in CsA+MPA); among those, 36 and 70 patients respectively remained on their randomization treatment. At M24, biopsy proven acute rejection (BPAR) and de novo donor specific antibodies (dnDSA) occurred more frequently in the CNI-free group (31.3 vs. 5.4%, p<0.001 and 34% vs. 11.6%). The mean eGFR by MDRD4 formula was comparable: 56.9 mL/min in the CNI-free group vs. 52.9 mL/min in the CsA+MPA group, p=0.54. Independent factors of BPAR at M24 were a positive epithelial to mesenchymal transition status at M12 and the CNI-free group. The incidence of cancer at M24 was 4.5% in the CNI-free group vs. 4.1% in the CsA+MPA group (ns) and MACE 4.5% vs. 5.4% (ns) respectively. Basal or squamous cell cancer occurred in 1 (1.5%) patient in the CNI-free group vs 3 (4.1%) in the CsA+MPA ns. Death occurred in 2 pts in the CNI-free group vs none in the CsA+MPA group, ns. No graft loss occurred. Safety was comparable in both groups.

Conclusion: At M24, an increased incidence of dnDSA was observed in both groups whilst BPAR increased in the CNI free group. A non-significant increase in the incidence of MACE was observed in the CsA+MPA group; incidence of cancer was similar. Longer follow up of this population could provide further evidence regarding incidence of cancer and MACE in RTx.

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