RecruitingPhase 3NCT05937750

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

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


Sponsor

Hansa Biopharma AB

Enrollment

150 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 76 Years

Inclusion Criteria3

  • 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 Criteria1

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

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Interventions

DRUGImlifidase 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.

OTHERBest 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.


Locations(14)

Medizinische Universitaet Wien

Vienna, Austria

Nephrology Clinic Vídeňská 1958/9

Prague, Czechia

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

Bois-Guillaume, Normandy, France

Hôpital Necker - Enfants Malades

Paris, France

Azienda Ospedaliera di Padova

Padova, Italy

Azienda Ospedaliero - Universitaria di Parma

Parma, Italy

Leiden University Medical Center

Leiden, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Hospital Del Mar, Servicio de Nefrología

Barcelona, Spain

Hospital Universitario del Vall d´Hebron

Barcelona, Spain

Unidad de Trasplante Renal

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Karolinska University Hospital,

Huddinge, Stockholm County, Sweden

Uppsala University Hospital

Uppsala, Sweden

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NCT05937750