Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients

16-2073

Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough levels and clinical outcomes. The primary endpoint of this study is to evaluate the proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney transplantation.

2017-02-06

2021-07-31

2022-06-28

Completed

Early phase I

97

Inclusion Criteria: * All new kidney transplant recipients aged 18 to 65 years who are admitted at UNC-CH and provided informed consent will be included in this study. Exclusion Criteria: - Patients will be excluded from participating in the study to receive genotype-guided tacrolimus dosing if he/she meets any of the exclusion criteria described below. * Recipients who did not consent to participate in the study. * Highly sensitized patients (ie, pretransplant T or B cell flow crossmatch positive) * Recipients of ABO incompatible kidney transplant * Recipients with preformed donor-specific antibodies (DSA) * Human Leukocyte Antigen (HLA) identical kidney transplant * Recipients of non-kidney transplant * Recipients of repeat transplant if they are on immunosuppression at the time of transplant * Patients using medications that have known pharmacokinetic (PK) drug interaction with tacrolimus * Patients in whom tacrolimus therapy is contraindicated

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 97, 'type': 'ACTUAL'}}

2023-06-26