Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months

Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).

Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.

Inclusion Criteria:

• Renal transplant recipients
• Age range: 18-70
• Patients taking MMF
• Able to understand and sign an informed consent

Exclusion Criteria:

• Active myelodepression
• Systemic infections or other that may affect MMF absorption
• Pregnancy/breastfeeding
• (History of) cancer
• Drug abuse, psychiatric conditions
• Already enrolled in other clinical trials or participation ended less than one month earlier
• Known sensitivity to polysorbate 80 or MMF