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Kidney transplant drug switch aims to reduce Long-Term risks

NCT ID NCT00811915

Disease control Sponsor: University Hospital, Rouen 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study looked at whether switching kidney transplant patients from tacrolimus to sirolimus (both with mycophenolate mofetil) could reduce long-term complications like kidney damage, diabetes, and cancer. It involved 65 stable transplant recipients between 12 and 36 months after surgery. The trial was terminated early, so results are limited.

What this could mean

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

Active substance
sirolimus (Rapamune)
What this could lead to
If successful, switching to sirolimus could lower the risk of long-term kidney damage, new diabetes, and skin cancer after a kidney transplant.
What could go wrong
This trial was terminated early with only 65 participants, so results are limited. The switch may cause rejection or other side effects, and findings may not apply to all transplant 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

65 people

The number who actually took part.

Start date

Jan 2009

Finished

Jun 2014

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 76 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: * Recipient age ≥18 and ≤ 75 ans. * Patients having received a first or second renal transplant from a cadaveric or living related donor between 12 and 24 months prior the inclusion. * Peak panel reactive antibody (PRA) \< 30 % * Patients with a stable renal function during the 3 months prior to inclusion (variation of serum creatinine lower than 20 %) * Creatinine clearance ≥ 40 ml/mn/1.73 m26. * Patients receiving as a stable immunosuppressive treatment associating: Mycophenolate mofetil (MPA AUC \> 30 mg.h/L) and Tacrolimus with a trough level \> 4 ng/ml, with or without corticoids Exclusion Criteria: * Multiorgan recipients * Patients receiving cyclosporine * Pregnancy * Recipients of ABO incompatible graft * Use of other immunosuppressive drugs. * Historical peak reactive antibody ≥ 30 % * Past medical history of humoral rejection, 2 episodes of acute cellular rejection * Past medical history of sub-clinical rejection on routine allograft biopsy * Calculated creatinine clearance \< 40 ml/mn/1.73 m2 * 24h proteinuria \> 1 g/24H * Patients with severe diarrhea * HTLV1 or HIV positivity * Known hypersensitivity to tacrolimus, mycophenolate mofetil, or sirolimus. * Total white blood cells \< 2500/mm3 or hemoglobin \< 9 g/dl

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As listed by the trial registrant

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

Kidney transplantation

Contacts and locations

Locations

  • UHAmiens

    Amiens, France

  • UHAngers

    Angers, 49933, France

  • UHCaen

    Caen, 14000, France

  • UHLimoges

    Limoges, France

  • UHNecker

    Paris, 75015, France

  • UHRennes

    Rennes, 35000, France

  • UHRouen

    Rouen, 76000, France

  • UHTours

    Tours, France

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