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

Hansa Biopharma

Status and phase: Enrolling; Phase 3

Conditions: Long Term Efficacy and Safety

Treatments: Drug: Imlifidase administered in the 20-HMedIdeS-19 (PAES) study; Other: Best available treatment administered in the 20-HMedIdeS-19 (PAES) study

Study type: Interventional

Funder types: Industry

Identifiers

NCT05937750

20-HMedIdeS-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 76 years old

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• Inability by the judgment of the investigator to participate in the trial for other reasons

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Imlifidase

Experimental group

Description:

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

Treatment:

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

Non-Comparative Concurrent Reference Cohort

Experimental group

Description:

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

Treatment:

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