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

NCT00297310 | Completed Phase 4

• 1 other identifier: CR005020
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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 body's immune system. For this reason, it works as an anti-rejection medicine.

Conditions

Kidney Transplantation; Transplantation

Keywords

Tacrolimus; Kidney transplantation; Transplantation; Kidney failure; chronic; P-Glycoprotein

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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)

Interventions

tacrolimus DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Pty Ltd: lead

Related Publications (1)

• Campbell S, Hawley C, Irish A, Hutchison B, Walker R, Butcher BE, Ferrari P. Pre-transplant pharmacokinetic profiling and tacrolimus requirements post-transplant. Nephrology (Carlton). 2010 Oct;15(7):714-9. doi: 10.1111/j.1440-1797.2010.01351.x.

  PMID: 21040167 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Janssen-Cilag Pty Ltd Clinical Trial

  Janssen-Cilag Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: May 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: April 1, 2007
• Last Updated: June 20, 2011

Record last verified: 2010-04