MedTrace Logo

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

NCT05714514 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2025-11-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Therese Åkerfeldt · Hansa Biopharma AB

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714514 on ClinicalTrials.gov