MPA Pharmacokinetics in Renal Transplantation

Completed

• Conditions: Kidney Transplantation Recipients
• Interventions: Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups

• Registration Number: NCT01892761
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-03
• Study Completion: 2005-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-03
• Last Update Submitted: 2013-07-03
• Study First Posted: 2013-07-04
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TCL/MMF Group	Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups	-
CyA/MMF Group	Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups	-

Primary Outcome Measures

Name	Time	Method
To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six months	6 months	To establish the dynamics of MPA-PK during the first six months following transplantation according to time and the CNI regimen used in 52 patients who had their full MPA-PK monitored in 5 post-transplant time-points.

Trial Locations

Locations (1)

Renal Transplantation Service; 🇧🇷 Sao Paulo, Brazil