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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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