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Gene test could Fine-Tune transplant drug dosing

NCT ID NCT00552201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adjusting the first dose of the immunosuppressant drug tacrolimus based on a patient's CYP3A5 gene helps reach the right blood levels faster after kidney transplant. 280 kidney transplant recipients were randomly assigned to receive either a standard dose or a dose tailored to their genetic profile. The goal was to see if more patients in the gene-guided group achieved target tacrolimus levels within the first week.

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 doctors personalize tacrolimus dosing for kidney transplant patients, potentially reducing the risk of rejection or side effects.
What could go wrong
This is a completed Phase 4 study with 280 participants, so results are available. However, the benefit may be limited to certain genetic groups, and the approach may not improve long-term outcomes.

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

280 people

The number who actually took part.

Start date

Apr 2006

Finished

Dec 2008

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

18 to 65 years

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: * Patients, male or female, 18 to 65 years old. * Patients receiving a first or a second isolated renal graft coming from a donor alive or deceased, * The patients in age to procreate must have a negative test of pregnancy before being included in this study and will have to agree to use effective contraceptive measurements throughout the study. -Patients able to include/understand the aims and the risks of the study, -having been fully informed and having given their writing consent to take part in this study. Patients unable to write and/or read but having fully understood the oral information given by the investigator and having given their oral consent in the presence of an independent witness. - Exclusion Criteria: * Patients who receive several grafts. * Patients requiring a treatment by azathioprin. * Pregnant woman or nursing mother * Patients receiving an incompatible graft ABO. * Patients receiving or requiring immunosuppressant drugs prohibited by the protocol. * Patients with a peak of historical antibody equal to or greater than 50% of the panel. * Patients suffering from serious gastro-intestinal disorders which interfere with their capacity to receive or to absorb an oral form and patients presenting severe diarrhoea. * Patients with symptomatic GI ulcer HIV or HTLV1 positive patients or their donors * Patients presenting or having presented in the 5 last years one or several malignant tumours, except baso or spinocellular cutaneous epithelioma successfully treated. * Patients with systemic infections requiring a treatment at the entry in the study. * Patients having a leukocyte numeration lower than 2,5.109/l or haemoglobin lower than 5g/dl. * Patients with drug-addiction whatever it is, or psychiatric disorder which, according to the point of view of the investigator, could invalidate the communication with investigator or interfere with the compliance of the patient. * Patients who take part simultaneously in another therapeutic test or who received a study treatment less than 30 days before the entry in this study. * Patients having already been included in this study. * Patients allergic or intolerant with corticoids, macrolides, Tacrolimus, mycophenolate mofetil or basiliximab

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU Angers

    Angers, France

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • CHU Limoges - Hôpital Dupuytren

    Limoges, 87042, France

  • CHU Poitiers- hôpital Jean Bernard

    Poitiers, 86021, France

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51092, France

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • CHU Rouen - Hôpital de Bois-Guillaume

    Bois-Guillaume, 76230, France

  • CHU Strasbourg - Hospices Civils

    Strasbourg, 67091, France

  • CHU Tours - Hôpital Bretonneau

    Tours, 37044, France

  • CHU de la côté de Nacre

    Caen, 14033, France

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