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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00780429

Enrollment

Registered

2008-10-27

Start date

2006-06-30

Completion date

Unknown

Last updated

2008-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

kidney, transplant, Mycophenolic acid, Inosine monophosphate dehydrogenase

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

Italy

Outcome results