Daclizumab Versus Rabbit Antithymocyte Globulin in High-Risk Renal Transplants: Five-Year Follow-up of a Randomized Study
Hellemans R, Hazzan M, et al.American Journal of Transplantation. 2015 Jul; 15(7): 1923-32
Aims
The objective of this observational follow-up study was to compare the efficacy and safety of rabbit ATG (rATG) and daclizumab in patients at high risk of acute rejection to 5 years posttransplant.
Interventions
rATG, daily administered between days 0-7 posttransplant versus five injections of daclizumab on days 0, 14, 28, 42 and 56.
Participants
236 renal transplant patients at high risk of acute rejection. All patients met one of the following risk factors: current panel reactive antibodies (PRA) >30%;,peak PRA >50%, loss of a first kidney graft from rejection within 2 years of transplantation, or two or three previous grafts.
Outcomes
Outcomes were proportion of patients with biopsy-proven acute rejection up to year 5 posttransplant, patient and graft survival at year 5, causes and risk factors for graft loss, renal function at year 5 (serum creatinine levels and estimated glomerular filtration rate according to the abbreviated Modified Diet in Renal Disease formula), proteinuria and blood pressure at year 5, and immunosuppressive therapy at year 5.
Follow-up
5 years
CET Conclusions
This is a five year follow up as an observational study of a randomised trial in which 227 de novo deceased donor kidney transplant recipients were randomised to induction with either rabbit antithymocyte globulin or daclizumab. The patients were selected for entry into the trial on the basis that they were defined as having a high immunological risk. In the five year follow up there was less biopsy proven acute rejection in the arm receiving thymoglobulin but patient and graft survival and renal function was comparable between the two groups. Thus ATG was superior to daclizumab in the prevention of rejection in these high immunological risk recipients but graft survival was very acceptable in both arms, namely 70% at 5 years. As daclizumab is no longer available the trial is of historical interest at this point in time.
Data analysis
Available case analysis
Quality notes
Previously assessed as Noel, C., D. Abramowicz, et al. (2009). "Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients." Journal of the American Society of Nephrology 20(6): 1385-1392.
Trial registration
Cochrane Renal Group - CRG020600038