Phase IV Trial to Evaluate Pre-emptive Genetic Testing for Personalized Tacrolimus Dosing in Patients Awaiting Kidney Transplant with Chronic Kidney Disease

What this Trial Is About

Researchers are conducting a phase IV multicenter clinical trial to determine if preemptive genotyping of patients with chronic kidney disease awaiting kidney transplant can improve the effectiveness and cost-efficiency of tacrolimus therapy compared to standard care. This trial is part of the larger iPHARMGx master protocol and focuses on identifying gene variants that affect drug response and adverse reactions. Participants will be preemptively tested for genetic variants related to tacrolimus metabolism. Those with actionable variants will be randomly assigned to either a group receiving tacrolimus dosing adjusted by genotype guidelines or a control group managed with standard dosing practices. Both groups will receive any commercially authorized tacrolimus formulation in Spain, and treatment adjustments will follow clinical pharmacogenetics recommendations or usual care accordingly. During the study, participants will be followed at specific time points to measure tacrolimus blood levels, treatment-related adverse events, transplant rejection rates, and healthcare costs. Outcomes such as achieving target drug concentrations and treatment modifications will be monitored over approximately 18 months. A Data Monitoring Committee will oversee safety and study validity throughout the trials duration.

Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus