To evaluate 1 and 3 year outcome of renal transplant recipients on generic Cyclosporine as the primary immunosuppressant.
Three hundred patients received live related renal transplant between March 2000 to September 2002. Immunosuppression was by triple drug regimen where generic Cyclosporin (Consupren) was used. Initial dose was 8mg/kg/day starting at day-2. AUC was undertaken in each case on day 5 by sparse sampling, levels at 0, 2, 3 and 6 hours. Initial dose adjustment were by AUC, thereafter by trough levels. Dose was reduced to 3-5mg/kg/day by six months. All graft dysfunctions were confirmed by biopsy. Each patient had more than 1 year follow-up period. Of the 300 recipients 235 were male and 65 female with a mean age of 30.6 ± 9.7 years. The mean age of donor was 33.2 ± 9.5 years with a M:F ratio of 1.4:1. Of the 300 recipient/donor pairs, 58 were HLA identical, 204 one haplotype matched and 38 less than one haplotype. At one year 81% of HLA identical and 58% of one haplotype transplants had serum creatinine less than 1.5mg/dl. Overall 3% of identical and 20% one haplotype experienced rejection episodes. The mean initial AUC was 5969 ± 1346 ng/ml/hour, mean trough was 310 ± 79 ng/ml and Cmax 985 ± 247 ng/ml. Cmax was observed at 3 hours in 74% of the recipients. Mean dose at 6 months was 5.1 ± 0.99 mg/kg/day, mean AUC was 3507 ± 843 ng/ml/hour and mean trough was 222 ± 89 ng/ml. Overall 1 and 3 year graft survival was 95% and 90% respectively. For HLA identical it was 98% and 98% and one haplotype 97% and 88%. The observed graft survival rates at 1 and 3 year and graft function grades at 1 year and episodes of rejection have led us to conclude that generic Cyclosporin (Consupren) is a safe and effective preparation and can be used as a primary immunosuppressants in a triple drug regimen.