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ACTIVE NOT RECRUITING
NCT05714514

Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys

Sponsor: Hansa Biopharma AB

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

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