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

Recruiting now · Phase 4

Conditions studied: Kidney Disease, Chronic, Transplant Recipient (Kidney), Immunosuppression

In brief

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.

Key facts

Study ID

NCT06701825

Run by

Instituto de Investigación Hospital Universitario La Paz

People needed

114

Starts

2025-06-02

Expected to finish

2026-12-31

Last updated by the study team

2025-09-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital La Paz — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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