Multicentre, controlled, randomised and single-blind, adaptive phase IV protocol to evaluate effectiveness and cost-effectiveness of a pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease population cohort: iPHARMGx TRANSPGx nested clinical trial

作者：Seco-Meseguer E, Stewart S, Diago-Sempere E, Jiménez C, Macías Carmona N, Fernández Solís J, Vila Santandreu A, Valero San Cecilio R, López Jiménez V, Carmona-Rodríguez M, López-Fernández LA, Imaz-Iglesia I, García-Saiz MDM, Farré M, Rodriguez-Jimenez C, Sanabria-Cabrera J, Rosas-Alonso R, García-García I, Borobia AM, iPHARMGx study group · 发表于：BMJ open · 年份：2026 · DOI：10.1136/bmjopen-2025-109279 · 被引用次数：22 · 研究领域：Tacrolimus、Immunosuppressive Agents、Kidney Transplantation、Renal Insufficiency, Chronic、Pharmacogenomic Testing、Graft Rejection、Humans、Cost-Benefit Analysis、Pragmatic Clinical Trials as Topic、Multicenter Studies as Topic、Single-Blind Method、Clinical Trials, Phase IV as Topic

INTRODUCTION: Genetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as tacrolimus, outside of tertiary hospitals is limited due to a lack of pharmacoeconomic evidence to support widespread implementation by healthcare policymakers. The iPHARMGx Consortium addresses this by developing the TRANSPGx clinical trial to assess the hypothesis that widespread adoption of a pre-emptive genotyping scheme in populations susceptible to receiving tacrolimus as immunosuppressive therapy following a kidney transplant is effective, cost-effective and feasible within the Spanish National Health System (SNHS) when compared to the standard of care tacrolimus dosing. METHODS AND ANALYSIS: The TRANSPGx trial is a multicentre, adaptive, randomised, controlled, pragmatic phase IV clinical trial nested within the iPHARMGx master protocol, with two parallel arms, aiming for superiority. Randomisation will be conducted on an individual basis with a centralised approach, with stratification by centre. After inclusion in the trial and completion of genotyping, subjects will be randomly allocated to either the experimental group (pharmacogenetic genotype-guided tacrolimus prescription) or the standard of care tacrolimus prescription (as deemed by the attending physician). The primary objective is to assess the effectiveness of a tacro...