NCT06701825 Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
| NCT ID | NCT06701825 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Condition | Kidney Disease, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 114 participants in total. It began in 2025-06-02 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures. 2. Subject or their legally authorized representative has voluntarily signed the informed consent document. 3. Participant is on the waiting list for a kidney transplant. 4. 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. 5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5. Exclusion Criteria: 1. Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients. 2. History of renal, heart, and/or liver transplant. 3. 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. 4. Any condition or situation precluding or interfering the compliance with the protocol. 5. Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06701825 clinical trial?
This trial is open to participants of all sexes, studying Kidney Disease, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06701825 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06701825 currently recruiting?
Yes, NCT06701825 is actively recruiting participants. Contact the research team at alberto.borobia@salud.madrid.org for enrollment information.
Where is the NCT06701825 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06701825 clinical trial?
NCT06701825 is sponsored by Instituto de Investigación Hospital Universitario La Paz. The trial plans to enroll 114 participants.
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