CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 434 enrolled
Drug / intervention
Daclizumab +4 moredrug
Likely dose
Daclizumab 1 mg/kg IV on Day 1 (within 12 hours post-op) and Days 8, 22, 36, 50; Mycophenolate mofetil 1.5 grams twice daily; Cyclosporine 1-4 mg/kg IV or 2-6 mg/kg orally; Methylprednisolone 500-1000 mg IV peri-operative then 0.5-1 mg/kg/day oral, tapered to 0.0-0.15 mg/kg/dayAI-extracted
Key inclusion· 3
  • ✓Undergoing first cardiac allograft transplant
  • ✓Negative pregnancy test within 48 hours pre-transplant (if applicable)
  • ✓Willing and capable of understanding risks and complying with study requirements
Key exclusion· 10
  • ✕Any previous organ transplant
  • ✕Receiving multiple organs in this transplantation
  • ✕Requiring ventricular assist device (VAD) post-transplant surgery
  • ✕WBC ≤2500/mm³, platelets ≤50,000/mm³, or hemoglobin ≤6 g/dL

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

Search/NCT00048165
NCT00048165Phase 4Completed
CompareCT.gov

A Double-Blind, Placebo -Controlled, Randomized Study to Assess the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation.

Hoffmann-La Roche·interventional·Posted Oct 25, 2002·Updated Jun 13, 2016

In Brief

A Phase 4 clinical trial evaluating Daclizumab, Methylprednisolone, and 3 other interventions for Heart Transplantation. Completed, enrolled 434 participants across 30 sites in 4 countries.

Detailed Summary

The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Transplantation
CountriesCanada, Germany, Sweden, United States
Collaborators--

Timeline

Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2002
Enrollment StartAug 1, 1999
Primary CompletionAug 1, 2002
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 23.7 years ago

Interventions

Daclizumabdrug

Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.

Methylprednisolonedrug

Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).

Mycophenolate mofetildrug

Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.

Placebodrug

Matching placebo will be administered on Days 1, 8, 22, 36, and 50.

cyclosporinedrug

Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.