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

NCT05937750 | Recruiting Phase 3

• 1 other identifier: 20-HMedIdeS-20
• Study Type: interventional
• Target: 150
• Locations: 7 countries
• Sites: 14

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.

Conditions

Long Term Efficacy and Safety

Keywords

Renal transplantation; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)

  Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.

  5-years after transplantation

Secondary Outcomes (16)

• Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)

  5-years after transplantation

• Graft failure-free survival (%) up to 2 and 3 years after transplantation

  2 and 3-years after transplantation

• Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels

  2, 3, and 5-years after transplantation

• Patient survival (%) after transplantation

  2, 3, and 5-years after transplantation

• Graft survival (%) after transplantation

  2, 3, and 5-years after transplantation

Study Arms (2)

Imlifidase

EXPERIMENTAL

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

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

Non-Comparative Concurrent Reference Cohort

EXPERIMENTAL

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

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

Interventions

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

Also known as: IdeS, HMED-IdeS, Idefirix

Imlifidase

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

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

Non-Comparative Concurrent Reference Cohort

Eligibility Criteria

• Age: 19 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hansa Biopharma AB: lead

Study Sites (14)

Medizinische Universitaet Wien

Vienna, 1090, Austria

RECRUITING

Nephrology Clinic Vídeňská 1958/9

Prague, 140-21, Czechia

RECRUITING

Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume

Bois-Guillaume, Normandy, 76230, France

RECRUITING

Hôpital Necker - Enfants Malades

Paris, 75015, France

RECRUITING

Azienda Ospedaliera di Padova

Padova, 35128, Italy

RECRUITING

Azienda Ospedaliero - Universitaria di Parma

Parma, 43100, Italy

RECRUITING

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, 3015 GD, Netherlands

RECRUITING

Hospital Del Mar, Servicio de Nefrología

Barcelona, 08003, Spain

RECRUITING

Hospital Universitario del Vall d´Hebron

Barcelona, 08035, Spain

RECRUITING

Unidad de Trasplante Renal

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Karolinska University Hospital,

Huddinge, Stockholm County, 14157, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Interventions

phenyl-2-aminoethyl sulfide

Study Officials

• Clinical Operations

  Hansa Biopharma AB

  STUDY DIRECTOR

Central Study Contacts

Central Contact

CONTACT

+46 46 16 56 70; clinicalstudyinfo@hansabiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 10, 2023
• Study Start: July 3, 2023
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); AU (1); FR (2); IT (2); CZ (1); SE (2); NL (2)