Protocol for taking pharmacogenetic testing of tacrolimus into the clinical arena: patient tailored anti-rejection therapy

Phase 1

• Conditions: The study is to determine whether MDR-1 genotyping correlates with tacrolimus dose in individual patients and could therefore be used in future to predict tacrolimus dose. All patients will have undergone or be about to undergo a kidney transplant and require treatment with tacrolimus immunosuppression.; MedDRA version: 8.1 Level: LLT Classification code 10021510 Term: Immunosuppression NOS

• Registration Number: EUCTR2006-005774-50-GB
• Lead Sponsor: Central Manchester & Manchester Children's University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-21
• Study Completion: 2011-10-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Subjects who have undergone a kidney transplant and are receiving oral tacrolimus as part of their clinical management
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any form of substance abuse (including drug or alcohol abuse) psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the patient's ability to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine in a well-powered study whether MDR-1 genotyping correlates with tacrolimus dose in individual patients and could therefore be used in future to predict tacrolimus starting dose.;Secondary Objective: ;Primary end point(s): The MDR-1 genotype of 400 patients taking tacrolimus. This information will be used to predict whether the patients are on standard, intermediate or reduced therapy dose.