Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00780429
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS Fondazione Policlinico San Matteo
🇮🇹Pavia, Italy