This trial is active, not recruiting.

Condition kidney transplantation
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.

United States No locations recruiting
Other countries No locations recruiting

Eligibility Criteria

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

Additional Information

Official title Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by IRCCS Policlinico S. Matteo.