A multi-cohort randomized Phase 2 open-label study to assess the preliminary efficacy safety and pharmacokinetics of BIVV020 for prevention and treatment of antibody-mediated rejection in adult kidney transplant recipients.

Are you eligible to participate in this study?

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

  • Conditions:
    Antibody-mediated Rejection
  • Age: Between 18 Year(s) - 75 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:

    Cohort A:
    1. Contraceptive use by men and women should be consistent methods of contraception for those participating in clinical studies.
    2. Participants with documented vaccinations against Neisseria meningitidis given within 5 years of enrollment, or initiated vaccinations at least 14 days prior to study intervention initiation.
    Cohort B:
    1. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not be eligible for this study if the following are true:

    1. History of severe cardiac disease such as chronic heart failure III-IV, myocardial infarction =6 months of enrollment, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular disease.
    2. Participants with known malignancy requiring active treatment within 3 years prior to study treatment initiation, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
    3. Known active ongoing infection such as:
      a) HIV, Hepatitis B, and/or Hepatitis C.
      b) Within 4 weeks of first study intervention: any serious infection, or infection requiring antibiotic treatment against an identified or suspected bacterial pathogen.
    4. History of active tuberculosis (TB) regardless of treatment.
    5. Participants with clinical diagnosis of systemic lupus erythematosus (SLE)
    6. Participants with prior (within the last 5 years) or concurrent non-renal solid organ transplant or hematopoietic stem cell transplant (HSCT).
    7. Participants who received off-label use of desensitization therapies with marketed therapies such as therapeutic plasma exchange/plasmapheresis/immunoadsorption, IVIg, rituximab, and imlifidase prior to study intervention initiation are eligible.
    8. Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation.
    9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
    10. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

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