Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants.
Lentine KL, Schnitzler MA, et al.Trials 2015; 16(1): 365.
Aims
To compare the long term efficicacy and safety of rabbit antithymocyte globulin (rATG) 10 years after transplantation
Interventions
Ten year post-transplant follow-up data was obtained from the 10-10 Study1 which compared 1-year post-transplant outcomes after treatment with rATG or basiliximab as part of immunosuppression regimens in deceased donor renal allograft recipients. 1. Brennan DC, et al. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355(19):1967–77.
Participants
183 adult recipients of renal transplants from deceased donors
Outcomes
The primary outcomes was the FDA specified composite triple endpoint of allograft rejection, graft failure, or patient death. Secondary outcomes included acute rejection, death-censored graft failure, and all-cause graft loss.
Follow-up
10 years
CET Conclusions
This study reports long-term outcomes of US patients enrolled in an in international trial comparing ATG and basiliximab in deceased donor kidney transplant recipients. At 10 years, outcomes were equivalent between the groups in terms of graft and patient survival, incidence of rejection and malignancy. Numbers are relatively small (no patients enrolled in European centres were included) meaning that there may not be enough statistical power to identify differences in outcomes such as malignancy. What is interesting here is the approach taken to collect long-term outcome data. US patients from the original trial were matched to the OPTN registry to obtain outcome data, removing the need for costly trial follow-up. In this case, patients were matched retrospectively resulting in some loss (4% patients could not be matched). The approach taken by the ongoing 3C study, prospectively flagging patients in the national registry, should help reduce inaccuracies. We would like to see this approach become a standard for the long-term follow-up of clinical trials in transplantation.
Data analysis
Strict intention-to-treat analysis
Quality notes
Score based on the previous study Brennan, DC et al. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355(19):1967-77
Trial registration
ClinicalTrials.gov - NCT00235300