Phase 4
Completed N=21
Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State
Source: ClinicalTrials.gov NCT00585468 ↗Enrolled (actual)
21
Serious AEs
—
Results posted
May 2016
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA) — 12.8; 18.7 micrograms per milliliter — p=0.0163
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA) |
12.8; 18.7 | 0.0163 sig |
| PRIMARY Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA) |
2.2; 1.7 | 0.039 sig |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA) |
5; 3 | — |
| PRIMARY Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA) |
56.5; 63.9 | 0.146 |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG) |
104.9; 113.0 | 0.4937 |
| PRIMARY Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG) |
59.4; 57.0 | 0.9669 |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG) |
3; 3 | — |
| PRIMARY Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG) |
967.5; 962.2 | 0.9607 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00585468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.