A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2030-04-30

Brief Summary

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A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.

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Detailed Description

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This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.

The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.

Conditions

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Long Term Efficacy and Safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor.

The rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Imlifidase

Imlifidase administered in the 20-HMedIdeS-19 (PAES) study

Group Type EXPERIMENTAL

Imlifidase administered in the 20-HMedIdeS-19 (PAES) study

Intervention Type 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.

Non-Comparative Concurrent Reference Cohort

Best available treatment administered in the 20-HMedIdeS-19 (PAES) study

Group Type EXPERIMENTAL

Best available treatment administered in the 20-HMedIdeS-19 (PAES) study

Intervention Type OTHER

Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.

Interventions

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Imlifidase administered in the 20-HMedIdeS-19 (PAES) 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.

Intervention Type DRUG

Best available treatment administered in the 20-HMedIdeS-19 (PAES) study

Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.

Intervention Type OTHER

Other Intervention Names

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IdeS HMED-IdeS Idefirix

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent obtained before any trial-related procedures
* Willingness and ability to comply with the protocol
* Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)