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

This study has been completed.
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Florida Identifier:
First received: September 14, 2005
Last updated: October 19, 2011
Last verified: October 2011
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.

Condition Intervention
Transplant, Kidney Drug: Mycophenolate mofetil + Tacrolimus Drug: Mycophenolate mofetil + Cyclosporin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial for Implementation of a MPA PK Monitoring Strategy

Resource links provided by NLM:

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of subjects with an average AUC between 30-60 ng x hr/mL [ Time Frame: 7 months ]

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

Enrollment: 24
Study Start Date: July 2003
Study Completion Date: December 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • MMF
  • CellCept
  • Ro 70-0003
  • Prograf
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:
  • MMF
  • CellCept
  • RO 70-0003
  • Neoral

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00187915

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Hoffmann-La Roche
Principal Investigator: Herwig-Ulf Meier-Kriesche, MD University of Florida
  More Information


Responsible Party: University of Florida Identifier: NCT00187915     History of Changes
Other Study ID Numbers: CEL330
20030499 ( Other Identifier: Western Institutional Review Board )
Study First Received: September 14, 2005
Last Updated: October 19, 2011

Keywords provided by University of Florida:
Renal transplant
Therapeutic drug level
Mycophenolate mofetil (MMF)
Mycophenolate Acid (MPA)
Oral Bioavailability

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on September 20, 2017