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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
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.
Details
| Lead sponsor | University of Utah |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2007-12 |
| Completion | 2011-07 |
Conditions
- Kidney Transplantation
Interventions
- Myfortic
Primary outcomes
- Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
- Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
- Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg\*h/mL) - Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
- Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG) — 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Countries
United States