RecruitingPhase 4

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

Spain114 participantsStarted 2025-06-02

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Tacrolimus concentrations levels

Timeframe: 4 days

Trial details

NCT IDNCT06701825

SponsorInstituto de Investigación Hospital Universitario La Paz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Alberto M. Borobia, MD, PhD

+34 912071466 alberto.borobia@salud.madrid.org

View on ClinicalTrials.gov More Kidney Disease, Chronic trials