MPA Pharmacokinetics in Renal Transplantation

NCT01892761 | Completed

• 1 other identifier: CAPPesq 1013/02
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation Recipients

Keywords

mycophenolate mofetil; mycophenolic acid; MPA; MMF; Pharmacokinetics; renal transplantation

Outcome Measures

Primary Outcomes (1)

• To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six 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.

  6 months

Study Arms (2)

TCL/MMF Group

Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups

CyA/MMF Group

Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups

Interventions

Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups DRUG

CyA/MMF Group; TCL/MMF Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Renal transplant recipients

Male and female patients aged 18-65 years, recipients of a non-HLA identical kidney allograft who presented a PRA \< 50% were eligible for the MoDIFY trial. Subjects were excluded if they received a non-renal organ, had current history of alcohol or illicit drug abuse, had liver enzymes more than two times the upper normal limit or received induction with anti-lymphocyte preparations.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Renal Transplantation Service

São Paulo, São Paulo, 05403-900, Brazil

Location

Study Officials

• Elias David-Neto, MD, PhD

  Renal Transplantation Service - Hospital das Clínicas - University of São Paulo School of Medicine, Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 4, 2013
• Study Start: September 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: June 1, 2005
• Last Updated: July 4, 2013

Record last verified: 2013-06

Locations

BR (1)