CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Mycophenolic Acid (Myfortic)drug
Likely dose
Mycophenolic Acid (Myfortic) 1080 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00374803
NCT00374803Phase 4Completed
CompareCT.gov

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

University of Cincinnati·interventional·Posted Sep 11, 2006·Updated Apr 28, 2016

In Brief

A Phase 4 clinical trial evaluating Mycophenolic Acid (Myfortic) for End Stage Renal Disease (ESRD). Completed, enrolled 45 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease (ESRD)
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2006
Enrollment StartApr 1, 2006
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago

Interventions

Mycophenolic Acid (Myfortic)drug

* 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).