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
Conditions
Interventions
Trade Name: Prograf
Pharmaceutical Form: Capsule, hard
Sponsors
Central Manchester & Manchester Children's University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed