Clinical trial NCT05937750: A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Long Term Efficacy and Safety
Keywords: Renal transplantation
Kidney transplantation
Lead sponsor: Hansa Biopharma AB
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
timeFrame: 5-years after transplantation
Secondary outcomes:
measure: Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)
timeFrame: 5-years after transplantation
measure: Graft failure-free survival (%) up to 2 and 3 years after transplantation
timeFrame: 2 and 3-years after transplantation
measure: Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels
timeFrame: 2, 3, and 5-years after transplantation
measure: Patient survival (%) after transplantation
timeFrame: 2, 3, and 5-years after transplantation
measure: Graft survival (%) after transplantation
timeFrame: 2, 3, and 5-years after transplantation
measure: Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)
timeFrame: 2, 3, and 5-years after transplantation
measure: Anti-drug antibody (ADA) levels (imlifidase cohort only)
timeFrame: 2, 3, and 5-years after transplantation
measure: Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)
timeFrame: 2, 3, and 5-years after transplantation
measure: Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)
timeFrame: 2, 3, and 5-years after transplantation
measure: Treatment of graft rejections
timeFrame: 2, 3, and 5-years after transplantation
measure: Treatment of graft rejection
timeFrame: 2, 3, and 5-years after transplantation
measure: Treatment of graft rejection
timeFrame: 2, 3, and 5-years after transplantation
measure: Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)
timeFrame: 2, 3, and 5-years after transplantation
measure: Use of immunosuppressive medication
timeFrame: 2, 3, and 5-years after transplantation
measure: Comorbidities
timeFrame: 2, 3, and 5-years after transplantation
measure: Change in patient reported life participation
timeFrame: 2, 3, and 5-years after transplantation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien
city: Prague
country: Czechia
facility: Nephrology Clinic Vídeňská 1958/9
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Barcelona
country: Spain
facility: Hospital Universitario del Vall d´Hebron
city: Barcelona
country: Spain
facility: Unidad de Trasplante Renal
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Hansa Biopharma AB
name: Clinical Operations
role: STUDY_DIRECTOR
References: