RENAL FUNCTION EVALUATION AFTER HALF DOSE REDUCTION OF NEORAL® IN COMBINATION WITH CELLCEPT® IN RENAL TRANSPLANT PATIENTS WITH ALTERED RENAL FUNCTION: PRELIMINARY 2 YEAR SAFETY AND EFFICACY RESULTS OF THE MMF-REFERENCE STUDY: A RANDOMISED, OPEN, MULTICENTRE, PROSPECTIVE, CONTROLLED STUDY

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O13 Aims: Long term outcome of renal allograft is largely affected by Chronic Allograft Nephropathy, where Calcineurin Inhibitors Induced Nephropathy plays a major role. Mycophenolate Mofetil (MMF, CellCept®) is a potent immunosuppressive (IS) drug without renal or metabolic toxicity. The aim of this randomised, prospective, multicentre clinical trial is to evaluate long term effect on renal function, of the introduction of MMF 2g/d, followed by a 50% Neoral® (CsA) reduction in renal transplant patients with altered renal function Methods: Patients at 1 to 10 years of renal transplantation receiving a CsA-based IS therapy, with a SeCr between 150 – 300 μmol/L were eligible. 103 were randomised (2:1 ratio). MMF group: MMF 2g/d with 50% CsA dose reduction (n=70); CsA group: CsA (Trough Levels > 100 ng/ml) +/− Azathioprine +/− steroids (n=33). Follow up is 96 weeks (W). Data are not locked, a complete statistical analysis will be communicated. Results: 65 (64,4%) patients completed 2-year follow up (median: 665 days). Baseline parameters: No statistical difference between groups at baseline except for weight and CsA dose: At the end of the W8, CsA Trough Level was 79±52 ng/ml in MMF group (n=55) and 133±49 ng/ml in CsA group (n=22). Efficacy: 2 year renal function evolution: In CsA group, mean 1/SeCr did not change from baseline: 0.0056±0.0009 (n=31) to 0.0057±0.0017 (n=20); (mean SeCr 181±27 to 208±140 μmol/L). In MMF group, mean 1/SeCr increased from 0.0054±0.0009 (n=69) to 0.0066±0.0014 (n=40); (mean SeCr 191±35 to 162±50 μmol/L). Safety results: At 2 years, 19 patients were withdrawn. Proteinuria was 0.5±0.75 ng/24h in MMF group (n=33) and 0.87±1.73 in CsA group (n=18). Conclusions: In this randomised, prospective, multicentre study, the improvement of renal function in the MMF arm confirms the 2-year benefit of Calcineurin inhibitors sparing with CellCept® 2g/d introduction in renal transplant patients with altered graft function. A (-year follow up is ongoing.