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Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
Sponsor: Hansa Biopharma AB
Summary
The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177).
Official title: A Prospective, Long-term Confirmatory Follow up Trial in Highly Sensitized Patients Treated With Imlifidase or Standard of Care in the ConfIdeS (20-HMedIdeS-17) Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
64
Start Date
2023-04-21
Completion Date
2029-12-31
Last Updated
2025-11-18
Healthy Volunteers
No
Interventions
Imlifidase administered in the ConfIdeS study
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.
Best available treatment administered in the ConfIdeS study
Institution-specific desensitization treatment prior to kidney transplantation in the ConfIdeS study OR remain on wait list for a more compatible organ offer if desensitization with institutional protocol is not appropriate
Locations (14)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Northwestern University, Dept. General Surgery, Div. Transplantation
Chicago, Illinois, United States
University of Chicago, Department of Surgery, Clinical Research Center
Chicago, Illinois, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Hospital Specialty and Transplant
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States