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

Launched by INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ · Nov 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether testing patients for specific genes before they receive a kidney transplant can help doctors choose the best treatment with tacrolimus, a medication used to prevent organ rejection. The study will compare this new approach, called "preemptive genotyping," to the current standard treatment to see if it is effective, cost-effective, and practical within the Spanish National Health System.

To be eligible for this trial, participants need to be on the waiting list for a kidney transplant and be willing to follow the study's procedures. They should not have previously undergone any genetic testing related to the gene being studied (CYP3A5) and must agree to participate. If enrolled, participants can expect careful monitoring throughout the study as researchers gather information on how well this new testing strategy works. It's important to note that individuals with certain medical conditions or who have had previous organ transplants may not be able to join the trial.

Gender

ALL

Eligibility criteria

• 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.