At a glance
ClinicalIndex Comparison Record- ✓About to undergo primary liver transplant (including living donor, non-heart beating donor, or split liver)
- ✓Age 18–75 years
- ✓Expected to tolerate first oral CNI dose within 24 hours post-transplantation
- ✕Multi-organ transplant or prior transplantation of any other organ
- ✕Urine production <200 mL within 12 hours post-reperfusion
- ✕Severe coexisting disease or unstable medical condition affecting study objectives
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
DELTA Study Dutch Evaluation in Liver Transplantation To Assess the Efficacy of Cyclosporine A Microemulsion With C-2h Monitoring Versus Tacrolimus With Trough Monitoring in de Novo Liver Transplant Recipients
In Brief
A Phase 4 clinical trial evaluating Cyclosporine A, Tacrolimus, and 3 other interventions for Liver Transplant. Completed, enrolled 171 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.
Study Details
Timeline
Interventions
Each patient was given two 20mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery.
Methylprednisolone was given as an intravenous bolus of 500mg during transplant surgery
Post-operatively prednisone was tapered from an initial dose of 20mg/day to zero at 3 months or continued at 5-10mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.