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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297310
First Posted: February 28, 2006
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen-Cilag Pty Ltd
  Purpose
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.

Condition Intervention Phase
Kidney Transplantation Transplantation Drug: tacrolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-transplant Pharmacokinetics as a Predictor of the Tacrolimus Dose Requirement Post Renal Transplantation

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • The proportion of patients that achieve a tacrolimus whole blood trough concentration of >=10 ng/mL by Day 3 post-transplantation

Secondary Outcome Measures:
  • Time to achieve first trough concentration of >=10 ng/mL. Comparative number of dose changes in each arm post-transplantation. Number of patients with whole blood trough concentration above the recommended therapeutic range (>15 ng/mL)

Enrollment: 89
Study Start Date: May 2004
Study Completion Date: April 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has end-stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation
  • Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor, at least 10 years of age, with compatible ABO blood type

Exclusion Criteria:

  • Patients receiving a graft from a non-heart-beating donor
  • known to have significant liver disease, or is receiving a graft from a hepatitis C or B positive donor
  • previously received or is receiving an organ transplant other than a kidney
  • taking diltiazem, or any of the other disallowed medications during the 7 days prior to, and the 30 day trial period, or has been taking an investigational drug in the past 28 days
  • patient or donor known to be HIV positive
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297310


Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00297310     History of Changes
Other Study ID Numbers: CR005020
First Submitted: February 24, 2006
First Posted: February 28, 2006
Last Update Posted: June 20, 2011
Last Verified: April 2010

Keywords provided by Janssen-Cilag Pty Ltd:
Tacrolimus
Kidney transplantation
Transplantation
Kidney failure
chronic
P-Glycoprotein

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action