A Randomized Pharmacokinetic Study of Generic Tacrolimus versus Reference Tacrolimus in Kidney Transplant Recipients.
Alloway RR, Sadaka B, et al.American Journal of Transplantation 12(10): 2825-2831,2012
Aims
To compare the steady-state pharmacokinetics of a generic tacrolimus formulation with the reference tacrolimus preparation in stable renal transplant patients.
Interventions
Generic tacrolimus formulation (Sandoz) versus the reference tacrolimus preparation (Prograf).
Participants
71 stable renal transplant patients.
Outcomes
Pharmacokinetic variables were area under the concentration-time curve from 0 to 24 hours post-dose, trough level and peak concentration. Clinical variables included the number of graft losses and episodes of rejection. Safety assessment included the incidence of adverse events and serious adverse events.
Follow-up
14 days
CET Conclusions
In this multicenter, open-label, crossover study, generic tacrolimus demonstrated a similar pharmacokinetic profile to the reference tacrolimus preparation. The study was conducted in kidney transplant recipients already maintained on Prograf, rather than healthy controls, to increase the clinical relevance. Data analysts were blinded to group assignment and the study was adequately powered. Drug profiles were within the ranges stipulated by both the Food and Drug Administration and European Medicines Agency. However, patients were required to take tacrolimus two hours before mealtimes, which may alter bio-availability, and the study did not address the issue of drug initiation.
Data analysis
Available case analysis
Trial registration
Not reported