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RECRUITING
NCT06701825
PHASE4

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

Sponsor: Instituto de Investigación Hospital Universitario La Paz

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-06-02

Completion Date

2026-12-31

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DRUG

Tacrolimus

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.

DRUG

Tacrolimus

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