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Kidney transplant drug showdown: which regimen saves more function?

NCT ID NCT01595984

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different combinations of immunosuppressant drugs in 88 adults who received a new kidney. The goal was to see which plan better protects kidney function over the short term. All participants took lifelong anti-rejection medication, so this is about managing the disease, not curing it.

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

88 people

The number who actually took part.

Started

May 2012

Finished

Mar 2024

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: * Males and Females aged between 18 and 70. * Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated. * Patient with a maximum PRA \<20%. * Patient wishing and being able to participate fully to the study, and having given a written consent. * Patient covered by a social insurance or beneficiary of such a regime. * Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment. Exclusion Criteria: * Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match. * Patient with a maximum PRA\> 20% twice. * Cold ischemic time \> 36 hours. * Patients with thrombocytopenia (\<75000/mm3), neutropenia (\<1 500 / mm3), leukopenia (\<2 500 / mm3) or a hemoglobin concentration \<8 g / dl, at inclusion visit. * Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy. * Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded. * Patient with severe systemic infections requiring continued therapy. * Treatment with an experimental drug within 4 weeks before the first dose of study treatment. * Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment. * Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol. * Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised. * Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator. * Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator. * Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method. * Patient under guardianship, or any patient protected by law.

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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

  • Nephrology Department, University Hospital of Montpellier

    Montpellier, 34285, France

  • Nephrology department, Hospital University of Amiens

    Amiens, 80000, France

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