CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
mycophenolate mofetil (MMF) +2 moredrug
Likely dose
mycophenolate mofetil (MMF) 1.0 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/NCT02091414
NCT02091414Phase 3Completed
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An Open Label Study to Evaluate the Effect of CellCept in Combination With Cyclosporine A and Steroids on Renal Function and the Prevention of Acute Rejection in Heart Transplant Patients.

Hoffmann-La Roche·interventional·Posted Mar 19, 2014·Updated Oct 29, 2014

In Brief

A Phase 3 clinical trial evaluating mycophenolate mofetil (MMF), cyclosporine A (CsA), and 1 other intervention for Heart Transplantation. Completed, enrolled 36 participants across 3 sites.

Detailed Summary

This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2014
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.3 years ago

Interventions

mycophenolate mofetil (MMF)drug

1.0 g PO BID

cyclosporine A (CsA)drug

Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL

corticosteroidsdrug

As per the practice of each participating center