Variability of mycophenolic acid elimination in the renal transplant recipients - population pharmacokinetic approach.
Velickovic-Radovanovic RM, Jankovic SM, et al.Renal Failure 2015; 37(4): 652-658.
Aims
To develop a population pharmacokinetic (PK) model for mycophenolic acid (MPA) in adult renal transplant recipients, to quantify the PK parameters, the variability between and within patients and the influence of covariates on the MPA pharmacokinetic parameters.
Interventions
Patients received oral Mycophenolate mofetil (MMF) (0.50 to 2.00 g/day), or enteric-coated mycophenolate sodium (EC-MPS) (0.54 to 1.44 g/day) as part of a triple immunosuppressive regimen, which also included corticosteroids (prednisolone) and cyclosporine or tacrolimus. Before analysis participants were randomized to either the model building group (n=70) or the validation group (n=25).
Participants
95 renal transplant recipients with stable graft function and immunosuppression regimen of tacrolimus or cyclosporine A-based therapy for at least three months prior to enrollment.
Outcomes
Data recorded were oral clearance, apparent volume of distribution , apparent volume of distribution in steady-state, intercompartment clearance, absorption rate constant, lag time between intake and absorption start (lag time), interindividual and residual variability, serum albumin, leukocytes,urea, hemoglobin, aspartate amino transferase, alanine amino transferase, gender, age, body weight, time after transplantation, diagnosis of diabetes mellitus, organ source and co-therapy.
Follow-up
Not applicable
CET Conclusions
No CET Conclusion
Quality notes
Quality Assessment not appropriate
Trial registration
None