Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
NCT ID: NCT05714514
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
64 participants
OBSERVATIONAL
2023-04-21
2029-12-31
Brief Summary
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Detailed Description
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After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.
Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Imlifidase administered in the ConfIdeS study
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previous participation in the clinical trial ConfIdeS.
Exclusion Criteria
ALL
No
Sponsors
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Hansa Biopharma AB
INDUSTRY
Responsible Party
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Principal Investigators
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Therese Åkerfeldt
Role: STUDY_DIRECTOR
Hansa Biopharma AB
Locations
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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
Countries
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Other Identifiers
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21-HMedIdes-25
Identifier Type: -
Identifier Source: org_study_id
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