Preemptive genetic testing to guide tacrolimus treatment for kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a nationwide, multi-centre, adaptive, single-blinded randomized Phase IV trial nested in the iPHARMGx master protocol that compares preemptive pharmacogenetic testing to current standard of care for patients likely to receive tacrolimus. Eligible transplant candidates will be genotyped for CYP3A5 before receiving tacrolimus; those with actionable variants will be randomized to guideline-based genotype-guided dosing or routine clinician-directed dosing. Participants will be followed prospectively at prespecified timepoints to capture drug levels, adverse drug reactions, clinical endpoints, and health-care resource use. A cost-effectiveness analysis will be performed alongside clinical outcomes, and an independent Data Monitoring Committee will review safety and trial conduct.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
2. Subject or their legally authorized representative has voluntarily signed the informed consent document.
3. Participant is on the waiting list for a kidney transplant.
4. 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.
5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5.

Exclusion Criteria:

1. Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
2. History of renal, heart, and/or liver transplant.
3. 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.
4. Any condition or situation precluding or interfering the compliance with the protocol.
5. Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.

Where it's running

• Hospital La Paz
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Alberto M. Borobia, MD, PhD
• Email: alberto.borobia@salud.madrid.org
• Phone: +34 912071466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.