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

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 3, 2023

Primary Completion Date

April 30, 2030

Study Completion Date

April 30, 2030

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.

Trial Locations (7)

1090

RECRUITING

Medizinische Universitaet Wien, Vienna

28041

RECRUITING

Hospital Universitario 12 De Octubre, Madrid

35128

RECRUITING

Azienda Ospedaliera di Padova, Padua

140-21

RECRUITING

Nephrology Clinic Vídeňská 1958/9, Prague

08035

RECRUITING

Hospital Universitario del Vall d´Hebron, Barcelona

08036

RECRUITING

Unidad de Trasplante Renal, Barcelona

751 85

RECRUITING

Uppsala University Hospital, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hansa Biopharma AB

INDUSTRY

NCT05937750 - A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group | Biotech Hunter | Biotech Hunter