Pilot Trial for Implementation of a MPA PK Monitoring Strategy (MPA)

October 19, 2011 updated by: University of Florida
This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant.

MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.

This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary or secondary cadaveric or living donor kidney recipients
  • On Cellcept

Exclusion Criteria:

  • Multi organ recipients
  • Documented non-compliance
  • Not on a calcineurin inhibitor
  • GFR <25 ml/min by Cockcroft Gault equation
  • Serum albumin <2.5 mg/dl
  • Pregnant
  • Active serious digestive disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CellCept + Prograf
Standard of Care Regime
Drug: Mycophenolate mofetil + Tacrolimus
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Other Names:
  • Prograf
  • CellCept
  • MMF
  • Ro 70-0003
OTHER: CellCept + Neoral
Standard of Care Regime
Drug: Mycophenolate mofetil + Cyclosporin
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Other Names:
  • CellCept
  • MMF
  • Neoral
  • RO 70-0003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with an average AUC between 30-60 ng x hr/mL
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of acute rejection of transplanted kidney
Time Frame: 7 months
7 months
Number of MPA related toxicities
Time Frame: 7 months
7 months
Number of dose changes required to obtain MPA AUC target in the first month
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

November 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 19, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL330
  • 20030499 (OTHER: Western Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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