Cyclosporine A is still the most important factor responsible for the survival of solid organ transplants worldwide. Trial objective was to investigate the feasibility and safety of conversion to a generic microemulsion cyclosporine A in stable renal transplant patients maintained on Neoral®. Seventy-five patients were enrolled from 8 centers in 5 Middle Eastern countries and monitored for six months after conversion to Sigmasporin Microral®, and readings at 0, ½, 1, 2, 3, 4.5 and 6 months were recorded including CyA blood level, S. creatinine, uric acid, liver enzymes, lipid profile, serum electrolytes, blood pressure and adverse events. 54 males and 21 females with an average age of 38.9 +10.7 years and transplant age of 30.3 +29.3 months, and maintained on Sigmasporin Microral® average dose of 2.8 +1.0 mg/Kg/day, were found to be stable throughout the study period as reflected by the stable CyA therapeutic blood level of C0 of 181.6 +102.1, C2 of 759.2 +384.4 and absorption profile represented by C2/C0 of 4.9 +2.8, and C2/ CyA dose of 282.3 +128.8. An average s. creatinine level of 116.1 +29.5 µmol/L was recorded denoting stable graft function and liver enzymes did not change significantly throughout the study period. No new onset cases of hypertension, diabetes mellitus or hyperlipidemia among the patients were reported. Grafts` functions were stable for all patients, except for two incidences of mild acute rejection and two of mild CyA nephrotoxicity, but graft and patients’ survival rates were 100% both. Results of this 6-month study showed that Sigmasporin Microral® is effective in maintaining stable renal functions in kidney transplant patients who had been converted from Sandimmune Neoral®, with similar safety and tolerability profile as reported in the international literature.
Volume : 6
Issue : 4
Pages : 213
King Abdul Aziz City Of Science and Technology. (KACST) and King Saud University, Riyadh, Kingdom of Saudi Arabia