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Kidney transplant trial tests which drug better prevents rejection

NCT ID NCT05385432

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial compares two induction therapies—rabbit anti-thymocyte globulin (rATG) and basiliximab—in 244 sensitized kidney transplant recipients who do not have pre-existing donor-specific antibodies. The goal is to see which drug better prevents biopsy-proven acute rejection within the first year after transplant. Participants will receive standard maintenance immunosuppression alongside the assigned induction therapy.

What this could mean

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

Active substance
Rabbit anti-thymocyte globulin (rATG) and basiliximab
What this could lead to
If successful, this trial could show which induction therapy is safer and more effective for preventing kidney transplant rejection in sensitized patients without donor-specific antibodies.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. Both drugs have known risks like infection and side effects, and the benefit of one over the other may be small or absent.

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

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

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 79 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 aged between 18-79 * Registered on the transplant waiting list * At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.) * Graft incompatibility rate (TGI) \< 85% * Ability for participant to comply with the requirements of the study * Written informed consent obtained from the participant * Participants covered by or entitled to social security. Exclusion Criteria: * DSA (negative virtual crossmatch with MFI threshold at 1000) * Combined transplantation * Usual contraindications to a kidney transplantation such as morbid obesity (BMI \> 40 kg/m2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure * Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II) * Incompatible ABO transplantation * Leukopenia lower than 3000/mm3 * Thrombocytopenia (platelets \< 50G/L) * Donor EBV Positive / Recipient EBV Negative * Active HIV infection (positive viral charge) * History of solid cancer (\< 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\<2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist. * History of lymphoma * Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal * Known hypersensitivity or contra-indication to rabbit proteins, basiliximab including the product excipients * Contra-indication to tacrolimus,mycophenolic acid ans steroids * Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion. * Patient under judicial protection, deprivation of liberty * Participation in other interventional research with an investigational drug or medical device.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 01-TOURS

    RECRUITING

    Tours, France

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