UK multicentre study to assess the safety and tolerability of Neoral in stable renal transplant patients

Abstract

The safety and tolerability of transferring maintained renal transplant patients from Sandimmun to Neoral is being assessed in a multicentre, open-label, single-arm study. A total of 250 patients has been enrolled and results are available from 75 patients up to 12 months post-transfer. A slight trend to higher mean cyclosporin trough levels was seen in this cohort, but trough levels were unchanged in the sub-group receiving ≥1 dose changes. The mean dose fell by 13%. Creatinine levels showed a slight overall upward trend. Blood pressure and uric acid were un-changed and adverse events were typical of those seen with Sandimmun. Neoral was well-tolerated. Data from the full cohort of 250 patients up to 3 months post-transfer support these findings. These results indicate that transfer from Sandimmun to Neoral is safe and well-tolerated and provides appropriate immunosuppression at a lower average dose than Sandimmun. The Neoral dose should be adjusted promptly, as required, to maintain the target trough level.