Actively Recruiting
Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-09-11
114
Participants Needed
1
Research Sites
82 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
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.
CONDITIONS
Official 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 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 participate and be followed-up for most of the study duration and adhere to study procedures
- Subjects must be naive to any genotyping test of the CYP3A5 gene
You will not qualify if you...
- Known hypersensitivity or allergy to tacrolimus or any excipients
- History of kidney, heart, or liver transplant
- History or evidence of any disease or condition that may interfere with absorption, distribution, metabolism, or excretion of the study treatment, except renal disease
- Any condition that interferes with compliance with the study protocol
- Any medical condition for which renal transplantation and/or study treatment should not be received
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
Research Team
A
Alberto M. Borobia, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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