drugset / Trial / NCT00297310

Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation

NCT00297310 ↗

Phase 4 Completed 89 enrolled Janssen-Cilag Pty Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation. Patients in one group will be treated with tacrolimus according current clinical practice. The other group will have a pre-transplant assessment of their tacrolimus blood level concentration that will be used to guide post-transplantation tacrolimus dosing. Tacrolimus is a medicine that slows down the body's immune system. For this reason, it works as an anti-rejection medicine.

Timeline

Start
2004-05
Primary completion
2006-10
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.05 mg/kg Oral
Subject Tacrolimus Small molecule 0.1 mg/kg Oral
Subject Tacrolimus Small molecule 0.15 mg/kg Oral
Subject Tacrolimus Small molecule 0.3 mg/kg Oral