CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Mycophenolate mofetil +2 moredrug
Likely dose
Mycophenolate mofetil 2.0 gfrom 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/NCT00717314
NCT00717314Phase 4Completed
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A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients

Hoffmann-La Roche·interventional·Posted Jul 17, 2008·Updated Sep 29, 2014

In Brief

A Phase 4 clinical trial evaluating Mycophenolate mofetil, CNI (50%), and 1 other intervention for Liver Transplantation. Completed, enrolled 87 participants across 11 sites.

Detailed Summary

This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + \>=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartMay 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.0 years ago

Interventions

Mycophenolate mofetildrug

1.5 to 2.0 g daily PO BID

CNI (50%)drug

50% reduction from BL

CNI (≥75%)drug

≥75% reduction from BL