RecruitingPhase 4NCT06701825

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

A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort


Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

114 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether testing a person's genes before a kidney transplant can help doctors better tailor the dosing of tacrolimus — a medication taken after transplants to prevent the body from rejecting the new organ. **You may be eligible if...** - You are on the waiting list for a kidney transplant - You are willing and able to participate and be followed up for most of the study - You have never had genetic testing for the CYP3A5 gene (which affects how your body processes tacrolimus) **You may NOT be eligible if...** - You have a known allergy to tacrolimus - You have previously had a kidney, heart, or liver transplant - You have a medical or surgical condition that significantly affects how your body absorbs or processes medications - You have any other condition that prevents safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTacrolimus

Tacrolimus at the dosage reccomended by the "Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing" based on the subjects pharmacogenetic phenotype.

DRUGTacrolimus

Subject allocated to this arm will receive tacrolimus according to clinical practice and the drug's product labelling. These subject will not receive a personalised dose based on their pharmacogenetic phenotype.


Locations(1)

Hospital La Paz

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06701825


Related Trials