Project Title: Development and Validation of Limited Sampling Strategies for Mycophenolate and Tacrolimus in Steroid-free Kidney Transplant Regimens (LSS MYCaTAC)
Last Update: Nov. 7, 2009
Project Staff: Dr. Nilu Partovi, Dr. Mary Ensom, Dr. Erica Greanya, Dr. Jean Shapiro, Dwayne Collins, Diane Decarie, Eric Poulin
Background
Patients who receive kidney transplants require immunosuppressants, and determining the optimal regimen of medications to prevent organ rejection while minimizing side effects is difficult. Recently, steroid-free regimens have been used, since steroids can have unfavorable side effect profiles. Our focus is to quantitatively assess if and how a steroid-free regimen affects the pharmacokinetics of tacrolimus and mycophenolate, specifically in kidney-transplant recipients
Methods
Thirty kidney-transplant recipients on a steroid-free regimen involving both tacrolimus (TAC) and mycophenolate (MMF) will have 10 blood samples drawn over a period of 12 hours (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12hrs), and their blood concentrations of TAC, MMF, MPAG, and AcMPAG (MPAG and AcMPAG are metabolites of MMF) will be determined. From this concentration over time data, pharmacokinetic models will be assembled calculating various parameters including Cl, Vd, Cmax, and AUC. A limited sampling strategy (LSS) will then be determined for both TAC and MMF, using only 3 time points within the first 4 hours. The LSS will be formed with 20 randomly selected patients, and will then be validated using the remaining 10 patients. These LSS’s will then be compared to previous LSS’s for mycophenolate and tacrolimus from the literature, to assess any differences in TAC and MMF pharmacokinetics in the presence vs. absence of steroids.
Results
We are currently in the process of recruiting patients and gathering data.
