Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297310
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2006-02-24
Brief Title:
Pre-transplant Assessment of Tacrolimus Blood Level Concentration as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
Sponsor:
Janssen-Cilag Pty Ltd
Organization:
Janssen-Cilag Pty Ltd
Study Overview
Official Title:
Pre-transplant Pharmacokinetics as a Predictor of the Tacrolimus Dose Requirement Post Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys immune system For this reason it works as an anti-rejection medicine
Detailed Description:
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 ngmL by Day 3 post-transplantation Patients randomized to Group 1 will take a single dose of tacrolimus 01 mgkg 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 03 mgkgday whereas patients that return a high tacrolimus blood concentration will have a post-transplantation starting dose of 01 mgkgday 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 ngmL 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 01 mgkgday orally Post-transplant 015 - 03 mgkgday as two divided tacrolimus doses orally the actual dose to be guided by the pre-transplant tacrolimus blood concentration
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 ngmL 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 01 mgkgday orally Post-transplant 015 - 03 mgkgday as two divided tacrolimus doses orally the actual dose to be guided by the pre-transplant tacrolimus blood concentration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None