Abstract
The patient and graft survival are the primary endpoints to evaluate safety and efficacy of the immunosuppressive treatments in renal transplantation. Today, however, the results are so good that a huge number of patients is needed to find statistically significant differences between treatments. Secondary endpoints are, therefore, used. Infections and other side effects are good endpoints for safety. Acute rejection is the best surrogate endpoint for efficacy. The diagnosis of acute rejection rests on an increase of plasma creatinine but how much the increase should be to define rejection is still unclear. Moreover, a number of noninvasive techniques can be used to exclude causes of graft dysfunction other than rejection. Thus, renal biopsy may be required to confirm the diagnosis. The severity of acute rejection may be used as a tertiary endpoint, but the criteria for assessing the severity of rejection still need to be standardized either based on clinical or histological variables.
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Ponticelli, C., Campise, M. Appropriate Endpoints for Renal Transplantation Clinical Trials. Ther Innov Regul Sci 31, 207–212 (1997). https://doi.org/10.1177/009286159703100129
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DOI: https://doi.org/10.1177/009286159703100129