Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Kidney Transplantation in Highly Sensitized Patients
Interventions
DRUG

Imlifidase

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

Normal Transplantation Routine

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

Trial Locations (22)

1000

Department of Nephrology , Zaloška 7, Ljubljana

1090

Medizinische Universitaet Wien, Vienna

3000

UZ Leuven - Campus Gasthuisberg, Leuven

9713

University Medical Center Groningen, Groningen

13353

Charité - Universitätsmedizin Berlin, Berlin

28041

Hospital 12 de Octubre, Madrid

35128

Azienda Ospedaliera di Padova, Padua

38700

CHU de Grenoble - Hôpital Michallon, La Tronche

43100

Azienda Ospedaliero - Universitaria di Parma, Parma

75015

Hôpital Necker - Enfants Malades, Paris

76230

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

81675

Klinikum rechts der Isar der Technische Universitaet Muenchen, Munich

140-21

Institut klinicke a experimentalni mediciny (IKEM), Prague

2333 ZA

Leiden University Medical Center, Leiden

3015 GD

Erasmus University Medical Center, Rotterdam

08003

Hospital Del Mar, Servicio de Nefrología, Barcelona

08036

Hospital Clínic de Barcelona, Unidad de Trasplante Renal, Barcelona

Unknown

Vall d'Hebron University Hospital (HUVH), Barcelona

141 57

Karolinska University Hospital, Huddinge

751 85

Uppsala University Hospital, Uppsala

LS9 7TF

St. James University Hospital, Leeds

LE5 4PW

Leicester General Hospital, Leicester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hansa Biopharma AB

INDUSTRY

NCT05369975 - Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts | Biotech Hunter | Biotech Hunter