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Kidney transplant hope: drug may remove antibody barriers

NCT ID NCT04294459

Disease control Sponsor: Sanofi 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tested a drug called isatuximab in 23 people waiting for a kidney transplant. The goal was to see if it could safely lower immune antibodies that make it hard to find a matching donor. The trial was stopped early, so we have limited information on how well it works.

What this could mean

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

Active substance
isatuximab (Sarclisa)
What this could lead to
If it worked, this could help more people with kidney failure find a compatible donor and receive a transplant.
What could go wrong
This was a very early (phase 1/2) trial that was terminated, so we don't know if it works. The drug can cause infusion reactions and other side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

23 people

The number who actually took part.

Started

Jun 2020

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening. * Body mass index (BMI) \</=40 kg/m\^2. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent. For Participants in Cohort A: active candidates on the kidney waitlist with living donor. For Participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation. Exclusion criteria: * Significant cardiac dysfunction. * Known active, recurrent, or chronic infection. * Active lupus or uncontrolled diabetes. * Prior treatment with rituximab within 6 months from SAR650984 administration. * Inadequate organ and bone marrow function at screening. * Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study. * Known intolerance or hypersensitivity to any component of SAR650984 or pre-medications. * Participants who were not suitable for participation as judged by the Investigator. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease immune system disorder

As listed by the trial registrant

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

Immune system disorder

Contacts and locations

Locations

  • Investigational Site Number :7240001

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

  • Investigational Site Number :7240002

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number :8400001

    Rochester, Minnesota, 55905, United States

  • Investigational Site Number :8400002

    New York, New York, 10016, United States

  • Investigational Site Number :8400003

    San Francisco, California, 94143, United States

  • Investigational Site Number :8400004

    Houston, Texas, 77030, United States

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