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

NCT05714514 | Active Not Recruiting FDA Drug

• 1 other identifier: 21-HMedIdes-25
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 14

Brief 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).

Conditions

Kidney Transplantation in Highly Sensitized Patients

Keywords

Desensitization; Highly sensitized; Positive crossmatch; Unlikely to be transplanted; Renal transplantation; Deceased donor

Outcome Measures

Primary Outcomes (1)

• Proportion of patients alive and free of dialysis at 3 years

  3 years after randomization in the ConfIdeS study

Secondary Outcomes (9)

• Proportion of patients alive and free of dialysis at 5 years

  5 years after randomization in the ConfIdeS study

• Proportion of patients alive at 3 and 5 years

  3 and 5 years after randomization in the ConfIdeS study

• Graft failure-free survival rates at 3 and 5 years

  3 and 5 years after randomization in the ConfIdeS study

• Graft survival rates at 3 and 5 years

  3 and 5 years after randomization in the ConfIdeS study

• Number of patients per wait-list category

  3 and 5 years after randomization in the ConfIdeS study

Study Arms (2)

Imlifidase administered in the ConfIdeS study

Drug: Imlifidase administered in the ConfIdeS study

Best available treatment administered in the ConfIdeS study

Other: Best available treatment administered in the ConfIdeS study

Interventions

Imlifidase administered in the ConfIdeS study DRUG

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.

Also known as: IdeS, HMED-IdeS

Imlifidase administered in the ConfIdeS study

Best available treatment administered in the ConfIdeS study OTHER

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

Best available treatment administered in the ConfIdeS study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177)

You may qualify if:

• Signed Informed Consent obtained before any trial-related procedures.
• Previous participation in the clinical trial ConfIdeS.

You may not qualify if:

• \. Inability by the judgement of the investigator to participate in the trial for any reason.

Sponsors & Collaborators

• Hansa Biopharma AB: lead

Study Sites (14)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35249, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Northwestern University, Dept. General Surgery, Div. Transplantation

Chicago, Illinois, 60611, United States

Location

University of Chicago, Department of Surgery, Clinical Research Center

Chicago, Illinois, 60637, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

New York University (NYU) Langone Transplant Institute, NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital Specialty and Transplant

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Therese Åkerfeldt

  Hansa Biopharma AB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: April 21, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)