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New hope for kidney patients with Hard-to-Match immune systems

NCT ID NCT05145296

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested two drugs, daratumumab and belatacept, in 5 highly sensitized dialysis patients waiting for a kidney transplant. The goal was to safely reduce the antibodies that make it very hard to find a compatible donor kidney. The trial was stopped early, but it aimed to help these patients get a transplant and keep the new kidney longer.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Jan 2022

Finished

Oct 2025

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 age 18-70 years * End Stage Renal Disease (ESRD) on dialysis * Patient listed and active for a deceased donor kidney transplant and have not received compatible donor offer for ≥3 year. * Calculated PRA ≥ 99% * Positive CMV serology * Positive EBV serology * Current vaccination for more than one month for diphtheria, tetanus, poliomyelitis, influenza, pneumococcus, meningococcus, herpes zoster and SARS CoV-2. * Patient affiliated to social security insurance or beneficiary of social security insurance Exclusion Criteria: * Inability or unwillingness of a participant to give written informed consent or comply with study protocol * Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including HIV, hepatitis B, hepatitis C, zoster) * Patient with positive hepatitis core antigen and/or positive hepatitis B surface antigen * Serious uncontrolled concomitant major organ disease * Any infection requiring hospitalization and intravenous antibiotics within 4 weeks of screening or Per os antibiotics within 2 weeks * Primary or secondary immunodeficiency * History of active tuberculosis (TB) (even if treated) or untreated latent TB * Malignancy within the last 5 years except documented and treated basal and squamous cell cancer of the skin * Alcohol, drug or chemical abuse within 1 year * Difficult peripheral venous access * Negative EBV serology * Negative CMV serology * Neutropenia (ANC \<1000/uL) or thrombocytopenia (platelet count \<100,000/uL) within 4 weeks prior to study entry * Patient previously treated with investigational products (belatacept, daratumumab) * Severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies * Hypersensitivity to any active substance or component of the investigational medicinal products * Any contra-indication to premedication drugs (paracetamol, dexchlorpheniramine, cetirizine, dexamethasone, montelukast) or post-medication drugs (corticosteroids, bronchodilators, valaciclovir) * Immunization with live vaccine within 2 months of study entry * Dry body weight ≥75kg. * Pregnancy or lactation * Females with childbearing status, defined as a premenopausal female capable of becoming pregnant, and not using an effective form of birth control. Effective birth control methods include oral, implant or patch hormone contraception; intrauterine device; abstinence and outercourse; tubal ligation; vasectomy. * Participant involved in another interventional clinical study * Person deprived of liberty by judicial order * Person under guardianship or curatorship

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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

  • Chu Grenoble

    La Tronche, 38700, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.