Tests genetic screening to adjust tacrolimus dosing in kidney transplant candidates
Tests genotyping before tacrolimus dosing in people with chronic kidney disease awaiting transplant.
Plain-language title generated from the registry record
Registry title: Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 4
Where in Spain
- Hospital La PazMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto de Investigación Hospital Universitario La Paz
- Trial code
- NCT06701825EU 2024-516596-32-00
- Record updated
- 11 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Any condition at medical discretion for which renal transplantation and/or study treatment should not be received; 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.