Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacokinetic Profile of Myfortic (Enteric Coated Mycophenolate Sodium) in a Rapid Steroid Withdrawal Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585468
First received: December 21, 2007
Last updated: October 18, 2012
Last verified: October 2012

December 21, 2007
October 18, 2012
December 2007
July 2011   (final data collection date for primary outcome measure)
Outcomes measured will include Cmax, Cmin, Tmax and AUC for Myfortic metabolites (MPA, MPAG, AcMPAG, freeMPA) and tacrolimus [ Time Frame: Dec 2007-Dec 2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585468 on ClinicalTrials.gov Archive Site
Outcomes measured will include Cmax, Cmin, Tmax and AUC for Myfortic metabolites (MPA, MPAG, AcMPAG, freeMPA) and tacrolimus [ Time Frame: Dec 2007-Dec 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Profile of Myfortic (Enteric Coated Mycophenolate Sodium) in a Rapid Steroid Withdrawal Protocol
Pharmacokinetic Profile of Myfortic (Enteric Coated Mycophenolate Sodium) in a Rapid Steroid Withdrawal Protocol in Combination With Tacrolimus in Stable Renal Transplant Recipients in the Fed and Fasting State

Mycophenolate sodium (Myfortic®) is an antiproliferative immunosuppressant used in transplantation. It was developed with the intention of improving the gastrointestinal side effect profile of mycophenolate mofetil (CellCept®). Mycophenolate sodium is formulated as an enteric coated tablet that releases mycophenolic acid (MPA) which in turn inhibits inosine monophosphate dehydrogenase (IMPDH).1 Through inhibition of IMPDH the de novo pathway of purine synthesis, which T and B lymphocytes rely on for proliferation, is blocked.1 The pharmacokinetic profile of mycophenolate sodium has mainly been studied in combination with cyclosporine and steroids.2 There is little information on the pharmacokinetics of mycophenolate sodium in combination with tacrolimus3 and currently no published information in steroid withdrawal. The metabolism and pharmacokinetics of mycophenolic acid differ when combined with cyclosporine or tacrolimus, leading to increased area under the curve (AUC) and Cmin with tacrolimus.4 The decrease in AUC with cyclosporine is due to an inhibition of MPAG excretion5, thus preventing the enterohepatic recirculation of MPAG and conversion back to MPA that is seen with tacrolimus. Mycophenolate sodium pharmacokinetics in the fed state have demonstrated a decrease of 33% in Cmax compared to a fasting state, as well as a delay in Tmax and lag time.1 However AUC, representing systemic exposure to MPA, was not significantly effected by food.1 The AUC values may vary by 20% or greater when mycophenolate sodium is administered with food. All current published data on the pharmacokinetics of MPA have been in patients receiving chronic corticosteroids as part of their immunosuppression regimen. As immunosuppression minimization, and especially corticosteroid withdrawal, become more popular it is important to understand how mycophenolate sodium and its metabolites behave in a 2 drug maintenance immunosuppression regimen. We propose to study the pharmacokinetic profile of mycophenolate sodium in patients on tacrolimus dose adjusted based on levels, and a steroid withdrawal protocol.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant
Drug: Myfortic
Drug-immunosuppressant
Other Names:
  • mycophenolate sodium
  • mycophenolic acid
1
Intervention: Drug: Myfortic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Renal transplant recipients greater than 18 years of age, who have given written consent

Exclusion Criteria:

  • taking medications that will interfere with the metabolism of the metabolism of tacrolimus or mycophenolate sodium
  • experienced an acute rejection episode prior to their pharmacokinetic profiles and if they have a serum creatinine >2 mg/dL
  • neutropenia (ANC < 1.3x103/mL)
  • received a previous transplant other than a kidney
  • receiving chronic steroids at time of transplant
  • known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid or any of its excipients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00585468
15121, Award# CERL080AUS33
No
University of Utah
University of Utah
Not Provided
Principal Investigator: Fuad Shihab, MD University of Utah
University of Utah
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP