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New drug aims to stop kidney transplant rejection

NCT ID NCT05156710

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This phase 2 trial tests a drug called BIVV020 in 48 kidney transplant recipients. The goal is to see if it can prevent or treat antibody-mediated rejection, a common cause of transplant failure. Participants receive BIVV020 plus standard care, and researchers monitor rejection rates and kidney function.

What this could mean

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

Active substance
BIVV020 (a drug given by injection to target the immune system)
What this could lead to
If successful, this could offer a new option to prevent or treat kidney transplant rejection, helping more people keep their transplanted kidney longer.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply to everyone. The drug may not work better than current treatments, and side effects are still being studied.

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

48 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

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 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: -Participant intended to receive SOC therapy per Investigator's judgment and local practice. Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor. Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR. * BMI ≤ 40 kg/m2. * Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). * Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). Exclusion Criteria: * Participants who are ABO incompatible with their donors. * Participants with known active ongoing infection as per below: 1. Positive HIV. 2. Positive HBV. 3. HCV with detectable HCV RNA. 4. Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention. * History of active tuberculosis (TB) regardless of treatment. * Participants with clinical diagnosis of systemic lupus erythematosus (SLE). * Prior treatment with complement system inhibitor within 5 times the half-life. * Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

transplant rejection prevention target

As listed by the trial registrant

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

Transplant rejection

Contacts and locations

Locations

  • Brigham & Women's Hospital- Site Number : 8400004

    Boston, Massachusetts, 02115, United States

  • Cedars-Sinai Medical Center- Site Number : 8400100

    Los Angeles, California, 90048, United States

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Investigational Site Number : 1240002

    London, Ontario, N6A 5A5, Canada

  • Investigational Site Number : 1240003

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1240101

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Investigational Site Number : 2500001

    Paris, 75010, France

  • Investigational Site Number : 2500002

    Créteil, 94010, France

  • Investigational Site Number : 2500005

    Toulouse, 31059, France

  • Investigational Site Number : 2500007

    Bordeaux, 33076, France

  • Investigational Site Number : 2760001

    Munich, 81675, Germany

  • Investigational Site Number : 2760002

    Berlin, 13353, Germany

  • Investigational Site Number : 2760004

    Essen, 45147, Germany

  • Investigational Site Number : 3800001

    Brescia, Lombardy, 25123, Italy

  • Investigational Site Number : 3800002

    Rome, Lazio, 00168, Italy

  • Investigational Site Number : 3800003

    Milan, Milano, 20162, Italy

  • Investigational Site Number : 3800004

    Bologna, Emilia-Romagna, 40138, Italy

  • Investigational Site Number : 7240002

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7520001

    Huddinge, 141 57, Sweden

  • Investigational Site Number : 7520002

    Uppsala, 751 85, Sweden

  • Massachusetts General Hospital- Site Number : 8400007

    Boston, Massachusetts, 02114, United States

  • NYU Langone Medical Center- Site Number : 8400102

    New York, New York, 10016, United States

  • University of California Los Angeles Medical Center- Site Number : 8400103

    Los Angeles, California, 90095, United States

  • University of California San Francisco - Parnassus Heights- Site Number : 8400001

    San Francisco, California, 94143, United States

  • University of Wisconsin Hospitals and Clinics- Site Number : 8400003

    Madison, Wisconsin, 53792, United States

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