Clinical trial of Tripterygium wilfordii Hook F. in human kidney transplantation in China

Objective. In this study, the effects of Triptergium Wilfordii Hook F(T II) were assessed on human kidney allograft rejection and long-term survival. Methods. This study compared treatment with T II(T II group, n = 121) to that without T II (control group, n = 102) among adult first cadaveric renal transplant recipients. The T II cohort of 121 recipients were divided into a regular dosage group (n = 82) and a double dosage group (n = 39). No antibody induction was administered to any patient. Results. Biopsy-proven early acute allograft rejection occurred in 4.1% of patients in the T II group versus 24.5% of patients in the control group. No rejection or repeated rejections occurred in the double dosage group at 3 months after transplantation. Acute rejection episodes were milder in the T II than the control group. The incidence of CD25+ cells > 10/mm(3) in the allografts at 3 months after transplantation was lower in the T II group than the control group, 15% and 50%, respectively. All patients tolerated T II well over the 5 years of this study. The 5-year graft survival censored for death with function was 96.7% in the T II group and 80.4% in the control group. Conclusion. T II was effective to prevent renal allograft rejection and increase long-term renal allograft survival among adult cadaveric renal transplant recipients.