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Study on Riliprubart for Preventing and Treating Antibody-Mediated Rejection in Adult Kidney Transplant Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Transplant Rejection, which can occur when the body’s immune system attacks a newly transplanted kidney. The study is investigating a treatment called BIVV020, also known by its code name SAR445088. This treatment is being tested to see if it can help prevent or treat this type of rejection in adults who have received a kidney transplant.

The purpose of the study is to evaluate how effective and safe BIVV020 is in managing transplant rejection. Participants in the study will be divided into two groups. One group will receive the treatment to see if it can prevent rejection from happening, while the other group will receive it to treat active rejection. The treatment is given as a solution for injection under the skin, and the study will monitor participants over a period of time to assess the treatment's effects.

Throughout the study, researchers will collect information on how well the treatment works, any side effects, and how the body processes the medication. This will help determine if BIVV020 is a viable option for managing transplant rejection in kidney transplant recipients. Participants will be closely monitored to ensure their safety and to gather comprehensive data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are assigned to one of two groups: Cohort A or Cohort B.

    Cohort A includes individuals with chronic kidney disease who will receive a kidney transplant.

    Cohort B includes kidney transplant recipients diagnosed with active antibody-mediated rejection (AMR).

  2. Step 2

    Treatment administration

    Participants receive the investigational medication BIVV020, which is administered as a solution for injection under the skin (subcutaneous).

    The dosage and frequency of administration are determined by the study protocol and the healthcare provider overseeing the trial.

  3. Step 3

    Monitoring and assessments

    Participants undergo regular monitoring to assess the effectiveness and safety of the treatment.

    This includes evaluating kidney function through laboratory tests, such as measuring the estimated glomerular filtration rate (eGFR) and protein: creatinine ratio.

    Participants are also monitored for any adverse events or side effects.

  4. Step 4

    Follow-up

    After completing the treatment period, participants continue to be monitored for a specified duration to assess long-term outcomes.

    This includes checking for the presence of anti-BIVV020 antibodies and evaluating the overall health of the kidney transplant.

  5. Step 5

    End of study

    The study is estimated to conclude by December 3, 2026.

    Participants will have completed all required assessments and follow-up visits by this time.

Who can join the trial?

6 criteria

  • Participants must be planning to receive standard care therapy as decided by the doctor and local practice.
  • For Cohort A: Participants should have chronic kidney disease and be scheduled to receive a kidney transplant from either a living or deceased donor.
  • For Cohort B: Participants must be kidney transplant recipients who have been diagnosed with active **AMR**. **AMR** stands for **Antibody-Mediated Rejection**, which is a type of transplant rejection.
  • Participants must have a **BMI** of 40 kg/m2 or less. **BMI** stands for **Body Mass Index**, which is a measure of body fat based on height and weight.
  • Women must use contraceptives during the treatment period and for at least 49 weeks after the last dose of the study medication or the last treatment visit.
  • Men must use contraceptives during the treatment period and for at least 49 weeks after the last dose of the study medication or the last treatment visit.

Who cannot join the trial?

5 criteria

  • Patients who have had a recent organ transplant and are experiencing transplant rejection cannot participate. Transplant rejection is when the body's immune system attacks the new organ.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

BIVV020 is a medication being studied for its potential to prevent and treat antibody-mediated rejection in adults who have received a kidney transplant. This study is exploring how effective and safe this medication is, as well as how it behaves in the body. The trial is divided into two groups: one group is looking at how well BIVV020 can prevent rejection, while the other group is examining its ability to treat active rejection.

What is already known about the treatment

BIVV020 – BIVV020 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials, specifically in a Phase 2 study, to assess its effectiveness and safety in preventing and treating antibody-mediated rejection in adult kidney transplant recipients. The main therapeutic indication for BIVV020 is to prevent and treat transplant rejection. At the molecular level, BIVV020 works by targeting specific components of the immune system to reduce the likelihood of the body rejecting a transplanted organ. It is classified pharmacologically as an immunosuppressant.

Investigated diseases

Transplant Rejection – Transplant rejection occurs when the recipient's immune system attacks the transplanted organ or tissue, recognizing it as foreign. This immune response can lead to inflammation and damage to the transplanted organ. There are different types of rejection, including acute and chronic, each with varying timelines and severity. Acute rejection can happen within weeks to months after the transplant, while chronic rejection may develop over years. The progression of transplant rejection can lead to a decline in the function of the transplanted organ. Monitoring and managing the immune response is crucial to prevent or minimize rejection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509936-25-00Protocol codeACT17012Estimated enrolment55 patientsSponsorSanofi-Aventis Recherche & Developpement

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