A Randomized Open-Label Multi-Centre Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients

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
    End Stage Renal Disease
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are donor kidney recipients
    2. Subjects should have the presence of donor specific antibodies (DSA(s))
    3. Subjects who are undergoing active Antibody Mediated Rejection (AMR)
    4. Subjects who have blood test results of at least 25% rise in serum creatinine compared to last individual value taken prior to the AMR.

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

    1. Subjects with previous treatment with imlifidase
    2. Subjects who underwent previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
    3. Subjects with significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
    4. Subjects who have taken other investigational drugs
    5. Subjects who have clinical relevant active infections
    6. Subjects who have known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients
    7. Subjects who are unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator
    8. Subjects who are unsuitable to participate in the study for any other reason as judged by the investigator
    9. Subjects with any condition that in the opinion of the investigator could increase the subject’s risk by participating in the study



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Contact the research team to learn more about this study.

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