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

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ClinicalTrials.gov Identifier: NCT00187915
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 20, 2011
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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 or disease Intervention/treatment Phase
Transplant, Kidney Drug: Mycophenolate mofetil + Tacrolimus Drug: Mycophenolate mofetil + Cyclosporin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : July 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : December 2004


Arm Intervention/treatment
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



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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187915


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

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187915     History of Changes
Other Study ID Numbers: CEL330
20030499 ( Other Identifier: Western Institutional Review Board )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents