Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

Literature regarding the effect of food on the pharmacokinetic (PK) profile of enteric-coated mycophenolate sodium combined with tacrolimus and corticosteroid withdrawal is lacking. The objective of this study is to identify pharmacokinetic variables of mycophenolate sodium (Myfortic®) in the fed and fasting state in stable renal transplant patients on tacrolimus in combination with a rapid steroid withdrawal protocol.

Key facts

Study ID

NCT00585468

Run by

University of Utah

People needed

21

Starts

2007-12-01

Expected to finish

2011-07-01

Last updated by the study team

2016-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium
• Experienced an acute rejection episode prior to the pharmacokinetic profile collection
• Serum creatinine >2 mg/dL
• Neutropenia (Absolute Neutrophil Count < 1.3x10\^3/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

Where it is running

• Univ of Utah-Solid Organ Transplant — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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