Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

IRCCS Policlinico S. Matteo

Status: Unknown

Conditions: Kidney Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT00780429

06/2006/REVO

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

54 participants in 3 patient groups

1

Description:

MMF+cyclosporine

2

Description:

MMF+tacrolimus

3

Description:

MMF+sirolimus