Pharmacokinetic and pharmacodynamic studies of two different rabbit antithymocyte antiglobulin dosing regimens: Results of a randomized trial.
Buchler M, Longuet H, et al.Transplant Immunology 2013; 28(2-3):120-6.
Aims
To investigate the pharmacokinetics of total and active rabbit antithymocyte globulin (rATG) and T-cell phenotype reconstitution after rATG administration in adult kidney transplant recipients.
Interventions
Patients were randomized to receive either 1.5mg/kg/day of rATG started intraoperatively and continued daily until day 3 or a 3mg/kg dose intraoperatively with a second infusion given at the same dose on day 3. All patients received tacrolimus, mycophenolate mofetil and steroids.
Participants
17 adult renal transplant recipients.
Outcomes
The primary outcomes included the pharmacokinetic and pharmacodynamic parameters of the two doses of rATG. The secondary outcomes included patient survival, graft survival, acute rejection, and the incidence of cytomegalovirus and BK virus infection.
Follow-up
12 months.
CET Conclusions
In this small and possibly underpowered study the authors have compared rabbit antithymocyte globulin given on days 0 and 3 at a dose of either 1.5mg/kg/day or 3mg/kg/day. Although there were some differences in the pharmacokinetics the immune reconstitution was the same in both groups and the authors conclude that the higher dose of rATG cannot be justified.
Data analysis
Per protocol analysis
Trial registration
Eudract - 2009-012673-35