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.
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.
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.
Instituto de Investigación Hospital Universitario La Paz
Lead sponsor
Instituto de Salud Carlos III
Collaborator