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RECRUITING
NCT05937750
PHASE3

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

Sponsor: Hansa Biopharma AB

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 76 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-07-03

Completion Date

2030-04-30

Last Updated

2026-04-24

Healthy Volunteers

No

Conditions

Long Term Efficacy and Safety

Interventions

DRUG

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.

OTHER

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.

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