drugset
drugset / Trial / NCT03020589

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

NCT03020589 ↗

Phase 4 Completed 97 enrolled University of North Carolina, Chapel Hill
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-02-06
Primary completion
2021-07-31
Completion
2022-06-28

Outcome

Missed primary endpoint

registry analysis (superiority test); CYP3A5 Based Tacrolimus Dosing vs Control; p = 0.58; Risk Ratio (RR) 1.27 (95% CI 0.67 to 2.05); Fisher Exact NCT03020589 ↗

registry analysis (superiority test); CYP3A5 Based Tacrolimus Dosing vs Control; p = 0.46; Risk Ratio (RR) 1.26 (95% CI 0.72 to 2.02); Fisher Exact NCT03020589 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.1 mg/kg —
Subject Tacrolimus Small molecule 0.2 mg/kg —

Indications

No indication recorded.