An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2019

Primary Completion Date

May 28, 2022

Study Completion Date

November 16, 2022

Conditions
Kidney Transplant Rejection
Interventions
DRUG

Imlifidase

Imlifidase is an immunoglobulin G (IgG) degrading enzyme of Streptococcus pyrogenes that cleaves all 4 human subclasses of IgG with strict specificity.

OTHER

Plasma Exchange

The subject's plasma is removed and discarded and the subject receives replacement donor plasma, albumin, or a combination of albumin and saline. IA may be used instead of PE to the discretion of the investigator. IA is achieved by passing a subject's plasma over columns that bind immunoglobulins and then the plasma is passed back to the subject.

Trial Locations (14)

1090

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW, Vienna

3050

The Royal Melbourne Hospital, Melbourne

5000

Royal Adelaide Hospital, Adelaide

10016

New York University Grossman School of Medicine, New York

13353

Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care, Berlin

30625

Medizinische Hochschule Hannover, Hanover

33076

Hôpital Pellegrin, Bordeaux

38043

CHU Grenoble Alpes - Néphrologie, dialyse et transplantation, Grenoble

55905

Mayo Clinic, Rochester

75475

Hôpital Saint-Louis. Service de Néphrologie et Transplantation, Paris

75743

Hôpital Necker - Service de Néphrologie - Transplantation, Paris

90048

Cedars-Sinai Medical Center, Los Angeles

02115

Brigham and Women Hospital, Boston

Unknown

Royal Prince Alfred Hospital, Sydney

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hansa Biopharma AB

INDUSTRY

NCT03897205 - An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients | Biotech Hunter | Biotech Hunter