Clinical trial

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

Name

21-HMedIdes-25

Description

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).

Trial arms

Trial start

2023-04-21

Estimated PCD

2027-12-31

Trial end

2029-12-31

Status

Recruiting

Treatment

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.

Arms:

Imlifidase administered in the ConfIdeS study

Other names:

IdeS, HMED-IdeS

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

Arms:

Best available treatment administered in the ConfIdeS study

Size

Primary endpoint

Proportion of patients alive and free of dialysis at 3 years

3 years after randomization in the ConfIdeS study

Eligibility criteria

Inclusion Criteria: 1. Signed Informed Consent obtained before any trial-related procedures. 2. Previous participation in the clinical trial ConfIdeS. Exclusion Criteria: 1. Inability by the judgement of the investigator to participate in the trial for any reason.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}

Updated at

2024-04-17

1 organization

Organization

Hansa Biopharma