Actively Recruiting
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
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-09-11
114
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Hospital Universitario La Paz
Lead Sponsor
I
Instituto de Salud Carlos III
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase IV multicenter clinical trial to determine if preemptive genotyping of patients with chronic kidney disease awaiting kidney transplant can improve the effectiveness and cost-efficiency of tacrolimus therapy compared to standard care. This trial is part of the larger iPHARMGx master protocol and focuses on identifying gene variants that affect drug response and adverse reactions. Participants will be preemptively tested for genetic variants related to tacrolimus metabolism. Those with actionable variants will be randomly assigned to either a group receiving tacrolimus dosing adjusted by genotype guidelines or a control group managed with standard dosing practices. Both groups will receive any commercially authorized tacrolimus formulation in Spain, and treatment adjustments will follow clinical pharmacogenetics recommendations or usual care accordingly. During the study, participants will be followed at specific time points to measure tacrolimus blood levels, treatment-related adverse events, transplant rejection rates, and healthcare costs. Outcomes such as achieving target drug concentrations and treatment modifications will be monitored over approximately 18 months. A Data Monitoring Committee will oversee safety and study validity throughout the trial's duration.
CONDITIONS
Brief Title
Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be willing and able to provide written informed consent prior to 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 be followed-up for most of the study duration and adhere to protocol procedures
- Subjects must be naive to genotyping testing of the CYP3A5 gene
You will not qualify if you...
- Known allergy or hypersensitivity to tacrolimus or any of its excipients
- History of kidney, heart, or liver transplant
- Any disease or condition interfering significantly with absorption, distribution, metabolism, or excretion of tacrolimus, except renal disease
- Any condition preventing compliance with the study protocol
- Any medical condition that contraindicates renal transplantation or study treatment as per physician discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive tacrolimus treatment either adjusted by genotype-guided dosing or according to standard clinical practice and product labeling.
Visits at day 4, week 4, week 15, and week 26 for drug level assessments and monitoring
Duration - Up to 18 months
Participants are prospectively followed to monitor effectiveness, safety, and healthcare costs related to tacrolimus treatment.
Periodic follow-up visits throughout the study duration
Trial Site Locations
Total: 1 location
1
Hospital La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Alberto M. Borobia, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here