64
Participants
Start Date
October 14, 2021
Primary Completion Date
June 20, 2025
Study Completion Date
June 20, 2025
Imlifidase
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
PLEX
PLEX is performed according to the respective site's standard procedure for desensitization.
IVIg
IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization.
Anti-CD20 antibodies
Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
Eculizumab
Eculizumab according to the respective site's standard procedure for desensitization.
Remain on wait list
Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
New York University (NYU) Langone Transplant Institute, NYU Langone Health, New York
Columbia University, New York
New York-Presbyterian - Weill Cornell Medical Center, New York
Hospital of the University of Pennsylvania, Penn Medicine, Philadelphia
Georgetown Transplant Institute, Washington D.C.
John Hopkins Hospital, Baltimore
University of Alabama at Birmingham (UAB) Hospital, Birmingham
University of Iowa Hospitals and Clinics, Iowa City
Medical College of Wisconsin, Milwaukee
University of Minnesota Medical School, Minneapolis
Mayo Clinic Rochester, Rochester
Northwestern University, Chicago
University of Chicago Medical Center, Chicago
Washington University School of Medicine, St Louis
Houston Methodist Hospital, Houston
Methodist Hospital Specialty and Transplant, San Antonio
Banner Health - University Medical Center - Phoenix, Phoenix
Mayo Clinic Phoenix, Phoenix
Keck Hospital of University of Southern California (USC), Los Angeles
Cedars-Sinai Medical Center, Los Angeles
Sutter Health - California Pacific Medical Center, San Francisco
University of Washington Medical Center, Seattle
University of California San Francisco (UCSF) Medical Center, San Francisco
Massachusetts General Hospital, Boston
Saint Barnabas Medical Center, Livingston
Lead Sponsor
Hansa Biopharma AB
INDUSTRY