NCT06701825RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 2 Jun 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Diseases
- Chronic kidney disease
- NCT number
- NCT06701825
- EU CT number
- 2024-516596-32-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 114
- From 2 Jun 2025 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
Other illness
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.