Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients
This trial is active, not recruiting.
|Sponsor||IRCCS Policlinico S. Matteo|
|Start date||June 2006|
|Trial size||54 participants|
|Trial identifier||NCT00780429, 06/2006/REVO|
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.
Male or female participants from 18 years up to 70 years old.
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
|Official title||Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months|
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