NCT05714514

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 64 (estimated)
• Sponsor: Hansa Biopharma AB · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer. 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

• Kidney Transplantation in Highly Sensitized Patients

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-21
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2023-02-06
• Last updated: 2025-11-18

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study