BIVV020 in Prevention and Treatment of Antibody-mediated Rejection (AMR)

Research Study of an Investigational Medication for Antibody-Mediated Rejection in Kidney Transplant Patients

Recruiting
18 years - 75 years
All
Phase 2
54 participants needed

Study Overview

Primary Objectives:
  • Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
  • Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
Secondary Objectives:
  • To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
  • To characterize the safety and tolerability of BIVV020 in kidney transplant participants
  • To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
  • To evaluate the immunogenicity of BIVV020

Study Details

Up to approximately 2 years

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Transplant Rejection
  • Age: 18 years - 75 years
  • Gender: All

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 to whom they are sensitized, and/or required
        desensitization prior to transplantation.
        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).
          -  18-75 years old at the time of consent.
        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 infection
                  requiring antibiotic treatment against an identified or suspected bacterial
                  pathogen.
          -  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.

Updated on 04 Apr 2025. Study ID: NCT05156710

This study investigates the use of an investigational medication in patients who have undergone or are about to undergo a kidney transplant and may experience antibody-mediated rejection (AMR). AMR is a condition where the body's immune system attacks the transplanted kidney. The purpose of this study is to evaluate how effective the investigational medication is in preventing or treating AMR in these patients.

Participants in the study will be divided into two study arms. One arm will receive the investigational medication along with standard care, while the other will receive only standard care. The study will monitor the safety and tolerability of the investigational medication, as well as how the body processes it, which is known as its pharmacokinetic profile. The study will also assess how the immune system responds to the investigational medication.

  • Who can participate: Adults aged 18 to 75 years who are either about to receive a kidney transplant or have already received one and are experiencing active AMR can participate. Participants must be willing to use contraception during the study and for 49 weeks after the last treatment. Key exclusions include active infections like HIV or hepatitis, and a history of tuberculosis.
  • Study details: Participants will receive either the investigational medication along with standard care or just standard care to study its effect on preventing or treating AMR.
  • Study Timelines: The study will last up to approximately 2 years.

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