Pilot Trial for Implementation of a MPA PK Monitoring Strategy

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00187915
First received: September 14, 2005
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of acute rejection of transplanted kidney [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Number of MPA related toxicities [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Number of dose changes required to obtain MPA AUC target in the first month [ Time Frame: 7 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187915     History of Changes
Other Study ID Numbers: CEL330, 20030499
Study First Received: September 14, 2005
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

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:
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014