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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

2026-01-26

Healthy Volunteers

No

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 (13)

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

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