Gene test could Fine-Tune transplant drug dosing
NCT ID NCT00552201
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
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280 people
The number who actually took part.
- Start date
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Apr 2006
- Finished
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Dec 2008
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHU Gabriel Montpied
Clermont-Ferrand, 63003, France
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CHU Limoges - Hôpital Dupuytren
Limoges, 87042, France
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CHU Poitiers- hôpital Jean Bernard
Poitiers, 86021, France
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CHU Reims - Hôpital Maison Blanche
Reims, 51092, France
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CHU Rennes - Hôpital Pontchaillou
Rennes, 35033, France
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CHU Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, 76230, France
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CHU Strasbourg - Hospices Civils
Strasbourg, 67091, France
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CHU Tours - Hôpital Bretonneau
Tours, 37044, France
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CHU de la côté de Nacre
Caen, 14033, France
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