Kidney Transplantation Clinical Trial
Official title:
Pre-transplant Pharmacokinetics as a Predictor of the Tacrolimus Dose Requirement Post Renal Transplantation
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.
This study is a multicentre, open-label, prospective, 2-arm, phase IV study of tacrolimus in
renal transplant recipients. Patients will be randomized to receive current clinical
practice or to have a pre-transplant pharmacokinetic assessment of tacrolimus metabolism
that will be used to guide post-transplantation tacrolimus dosing, with the aim of
increasing the proportion of patients that achieve a tacrolimus whole blood trough level of
>10 ng/mL by Day 3 post-transplantation. Patients randomized to Group 1 will take a single
dose of tacrolimus (0.1 mg/kg) prior to transplantation and a blood sample will be taken to
determine tacrolimus whole blood concentration at 2 hours post-dose. The result of this
blood sample will be used to guide tacrolimus dosing post-transplantation. Patients that
return a low tacrolimus blood concentration will have a post-transplantation starting dose
of up to 0.3 mg/kg/day, whereas patients that return a high tacrolimus blood concentration
will have a post-transplantation starting dose of 0.1 mg/kg/day. Patients randomized to
Group 2 will also receive a single pre-operative dose of tacrolimus, but will not have their
tacrolimus whole blood concentration measured at 2 hours post-dose. These patients will be
managed as per standard care.
The primary objective of the trial is to compare, between the two groups, the proportion of
patients that achieve a tacrolimus whole blood trough concentration of ³10 ng/mL by Day 3
post-transplantation. The hypothesis is that performing a tacrolimus whole blood
concentration assessment 2 hours after a pre-operative dose (to guide tacrolimus dosing
post-transplantation), will lead to an increase in the numbers of patients that achieve
therapeutic blood concentrations post-transplant. The tacrolimus whole blood concentration
at Day 3 post-transplantation is a marker of the risk of rejection and toxicity.
A substudy is being conducted which seeks to examine and compare clinical variability in
absorption profile by measurement of the phenotype (blood levels) in kidney transplant
recipients and determine the nature and extent of relationship with MDR-1 genotype, thus
allowing the most predictive and cost effective method of determining tacrolimus dosing.
Pre-transplant: One single tacrolimus dose 0.1 mg/kg/day orally. Post-transplant: 0.15 - 0.3
mg/kg/day as two divided tacrolimus doses orally, the actual dose to be guided by the
pre-transplant tacrolimus blood concentration.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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