RecruitingPhase 4NCT06701825

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

A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

114 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Disease, Chronic Immunosuppression Transplant Recipient (Kidney)

Summary

This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.

Eligibility

Inclusion Criteria5

Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
Subject or their legally authorized representative has voluntarily signed the informed consent document.
Participant is on the waiting list for a kidney transplant.
Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
Subjects must be naïve to any genotyping test of the following genes: CYP3A5.

Exclusion Criteria5

Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
History of renal, heart, and/or liver transplant.
History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
Any condition or situation precluding or interfering the compliance with the protocol.
Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.

Interventions

DRUGTacrolimus

Tacrolimus at the dosage reccomended by the "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing" based on the subjects pharmacogenetic phenotype.

DRUGTacrolimus

Subject allocated to this arm will receive tacrolimus according to clinical practice and the drug's product labelling. These subject will not receive a personalised dose based on their pharmacogenetic phenotype.