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

NCT00585468 | Completed Phase 4 Results

• 2 other identifiers: 15121Award# CERL080AUS33
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (8)

• 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)

  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)

  0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

• 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

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)

  0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

• Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)

  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)

  0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

Study Arms (2)

Myfortic - Fed State

EXPERIMENTAL

Mycophenolate sodium taken with a meal.

Drug: Myfortic

Myfortic - Fasting State

EXPERIMENTAL

Mycophenolate sodium taken separately from food by 2 hours.

Drug: Myfortic

Interventions

Myfortic DRUG

Myfortic 720 mg orally twice daily

Also known as: mycophenolate sodium, mycophenolic acid

Myfortic - Fasting State; Myfortic - Fed State

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Univ of Utah-Solid Organ Transplant

Salt Lake City, Utah, 84119, United States

Location

Related Publications (4)

• Arns W, Breuer S, Choudhury S, Taccard G, Lee J, Binder V, Roettele J, Schmouder R. Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant. 2005 Apr;19(2):199-206. doi: 10.1111/j.1399-0012.2004.00318.x.

  PMID: 15740555 BACKGROUND

• Kaplan B, Meier-Kriesche HU, Minnick P, Bastien MC, Sechaud R, Yeh CM, Balez S, Picard F, Schmouder R. Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium. Clin Transplant. 2005 Aug;19(4):551-8. doi: 10.1111/j.1399-0012.2005.00387.x.

  PMID: 16008604 BACKGROUND

• Zucker K, Rosen A, Tsaroucha A, de Faria L, Roth D, Ciancio G, Esquenazi V, Burke G, Tzakis A, Miller J. Unexpected augmentation of mycophenolic acid pharmacokinetics in renal transplant patients receiving tacrolimus and mycophenolate mofetil in combination therapy, and analogous in vitro findings. Transpl Immunol. 1997 Sep;5(3):225-32. doi: 10.1016/s0966-3274(97)80042-1.

  PMID: 9402690 BACKGROUND

• van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit. 2001 Apr;23(2):119-28. doi: 10.1097/00007691-200104000-00005.

  PMID: 11294511 BACKGROUND

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Fuad Shihab, MD
• Organization: University of Utah

fuad.shihab@hsc.utah.edu

801-585-3823

Study Officials

• Fuad Shihab, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 6, 2016
• Results First Posted: May 6, 2016

Record last verified: 2016-04

Locations

US (1)