CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
mycophenolate mofetil +3 moredrug
Likely dose
mycophenolate mofetil 1 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/NCT01292226
NCT01292226Phase 2Completed
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Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil

Hoffmann-La Roche·interventional·Posted Feb 9, 2011·Updated May 12, 2016

In Brief

A Phase 2 clinical trial evaluating mycophenolate mofetil, antibody induction, and 2 other interventions for Kidney Transplantation. Completed, enrolled 45 participants across 7 sites.

Detailed Summary

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2011
Enrollment StartDec 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.4 years ago

Interventions

mycophenolate mofetildrug

1 g PO BID for 24 weeks

antibody inductiondrug

According to manufacturer recommendation

Cyclosporinedrug

According to manufacturer recommendation

corticosteroiddrug

According to manufacturer recommendation