New hope for kidney patients with Hard-to-Match immune systems
NCT ID NCT05145296
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.
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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
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Oct 2025
- Lead sponsor
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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
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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Other studies related to the condition(s) this trial covers.
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