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Gene test before kidney transplant could prevent drug dosing errors

NCT ID NCT06701825

Disease control Sponsor: Instituto de Investigación Hospital Universitario La Paz Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether checking a patient's genes before a kidney transplant can help doctors choose the best starting dose of the anti-rejection drug tacrolimus. About 114 adults on the transplant waiting list will be randomly assigned to either standard dosing or a dose based on their genetic profile. The goal is to see if the genetic approach helps patients reach the ideal drug level faster, which could lower the risk of rejection and reduce side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tacrolimus
What this could lead to
If successful, this approach could help kidney transplant patients reach the right drug levels faster, reducing rejection risk and side effects.
What could go wrong
This is a relatively small, early-phase trial (114 people) focused on drug dosing, not a new treatment. The benefit may be modest and may not apply to all patients or healthcare systems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunosuppression Kidney disease, chronic Transplant recipient (kidney)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

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