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New drug could help 'Incompatible' kidney transplants succeed

NCT ID NCT07379957

Disease control Sponsor: University Hospital, Bordeaux 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests imlifidase, a drug that temporarily disables the immune system's antibodies, allowing highly sensitized patients to receive a kidney from a deceased donor they would otherwise reject. The trial will follow 450 patients in France to see how many get transplanted and how well the kidneys survive long-term. Early results suggest it can convert a positive crossmatch to negative in most patients, but antibody rejection and graft loss are still concerns.

What this could mean

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

Active substance
Imlifidase (a drug that temporarily disables antibodies)
What this could lead to
If successful, this could help more highly sensitized patients get a kidney transplant and improve long-term graft survival.
What could go wrong
This is based on two small studies; antibody rejection and graft loss remain possible. Long-term data are still being collected.

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.

Participants

About 450 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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.

Who is studied

When a kidney transplant candidate eligible to imlifidase is identified in a transplant center in France, HLA antibodies are delisted by the HLA laboratory, according to the French guidelines. Following this delisting, the patients can be transplanted with or without imlifidase or stay on dialysis. Bordeaux University Hospital will establish agreements with the 20 other university hospitals who have patients eligible to imlifidase. An implementation visit will be carried out at each CHU to: 1. identify patients already eligible for imlifidase, 2. set up a system to inform the Bordeaux CHU, as the coordinating center, when new incident patients eligible for imlifidase are identified, 3. offer all identified patients' inclusion in the ISKIA study

Ages

18 years and older

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: * Highly sensitized adult kidney transplant candidates * Eligible to imlifidase (patient with a delisting of at least one A, B, DR, DQ HLA antibody) Exclusion Criteria: * Age \< 18 years-old

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

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

Kidney transplantation

How to take part

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

  1. The places running it

    20 sites. 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

  • CHU Amiens Picardie Site Sud

    Amiens, 80000, France

  • CHU Caen Normandie

    Caen, 14000, France

  • CHU Saint Etienne

    Saint-Etienne, 42000, France

  • CHU Tours Bretonneau

    Tours, 37000, France

  • CHU de Grenoble Alpes

    Grenoble, 38000, France

  • CHU de Nantes

    Nantes, 44000, France

  • CHU de Reims

    Reims, 51000, France

  • CHU de Strasbourg

    Strasbourg, 67000, France

  • Hôpital Bicêtre

    Paris, 75000, France

  • Hôpital Edouard Herriot

    Lyon, 69000, France

  • Hôpital Foch

    Suresnes, 92000, France

  • Hôpital Henri Mondor

    Créteil, 94000, France

  • Hôpital Huriez

    Lille, 59000, France

  • Hôpital Necker

    Paris, 75000, France

  • Hôpital Pasteur

    Nice, 06000, France

  • Hôpital Pellegrin

    Bordeaux, 33000, France

  • Hôpital Rangueil

    Toulouse, 31000, France

  • Hôpital Saint-Louis

    Paris, 75000, France

  • Hôpital de Bois-Guillaume

    Bois-Guillaume, 76000, France

  • Hôpital de la Conception

    Marseille, 13000, France

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