NCT00374803

Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Detailed description

Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Conditions

• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DRUG	Mycophenolic Acid (Myfortic)	* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter * Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-09-11
• Last updated: 2016-04-28
• Results posted: 2012-05-08

Locations

2 sites across 1 country: United States