Objective To evaluate the efficacy and safety of rabbit anti-human thymocyte immuneglobulin (rATG) induction therapy in kidney transplant recipients from donation after cardiac death in China.
Methods This was a prospective, multicenter, single-arm and interventional study conducted in China (NCT03099122). Adult patients who underwent kidney transplantation from donation after cardiac death and received rATG induction therapy (cumulative dose of 5 mg/kg) were included. Univariate and multivariate logistic regression analyses were used to identify factors associated with acute rejection (AR), delayed graft function (DGF), graft failure, and patient death. The occurrence of adverse events was also analyzed.
Results A total of 115 adult patients were enrolled in the study, of whom 107 were evaluable for efficacy. The incidence of biopsy-proven acute rejection (BPAR) and acute rejection (AR) was 2.8% (95% confidence interval 0.6%–8.0%) and 4.7% (95% confidence interval 1.5%–10.6%), respectively. The incidence of delayed graft function (DGF) was 13.1% (95% confidence interval 7.3%–21.0%). Graft and patient survival rates were 97.2% (95% confidence interval 92.0%–99.4%) and 99.1% (95% confidence interval 94.9%–100%), respectively. Multivariate logistic regression analysis showed that donor serum creatinine and recipient panel reactive antibodies were risk factors for DGF (both P<0.05). Common treatment-emergent adverse events (incidence >5%) included anemia (8.7%), infectious pneumonia (8.7%), and urinary tract infection (8.7%).
Conclusions Standard-dose rATG induction therapy demonstrates low incidences of BPAR, AR, and DGF, and good safety in Chinese kidney transplant recipients from donation after cardiac death.
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