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Kidney transplant drug dosing gets a closer look

NCT ID NCT01435291

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This completed study looked at how the drug Advagraf (a form of tacrolimus) works in 45 adults who received a kidney transplant. The goal was to find better ways to dose the drug by measuring its levels in the blood right after transplant and three months later. Researchers compared Advagraf with another version of the same drug called Prograf.

What this could mean

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

Active substance
Advagraf (tacrolimus prolonged release)
What this could lead to
If successful, this could help doctors give more precise doses of Advagraf to kidney transplant patients, potentially reducing side effects and improving outcomes.
What could go wrong
This is a small, completed pharmacokinetic study, not a large trial testing a new treatment. The findings may not change standard practice or apply to all patients.

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

45 people

The number who actually took part.

Start date

Oct 2011

Finished

Jul 2013

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 70 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: * Adult recipients aged between 18 to 70 * Primary renal transplantation * Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type. * absence of anti-LHA antibodies in lymphocytotoxicity and Luminex * Negative cross-match in cytotoxicity * Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study Exclusion Criteria: * Combined transplantation * Renal bigraft * History of any other transplantation * Receiving a graft from a non-heart-beating donor. * Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation * Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp. * Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer * Subject or donor known to be HIV positive * Active viral hepatitis (VHB, VHC) at randomisation * Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients * Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. * Current participation in any other clinical study * Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study * Patient not able to comply with the study procedures * Breast-feeding mother

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Renal transplantation

Contacts and locations

Locations

  • CHRU Tours Hôpital Bretonneau

    Tours, France

  • CHU de Nice

    Nice, 06200, France

  • CHU de Rangueil

    Toulouse, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, France

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