50
Participants
Start Date
December 22, 2022
Primary Completion Date
June 23, 2025
Study Completion Date
November 30, 2026
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.
Plasma exchange (PLEX)
PLEX removes the patient's pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.
Cyclophosphamide (CYC)
Cyclophosphamide's main mechanism of action (i.e. crosslinking of strands of DNA and RNA) results in inhibition of protein synthesis. Hence treatment prevents formation of new anti-GBM antibodies.
Glucocorticoids
Glucocorticoids inhibit the inflammation process.
Medical University of Vienna, Dept of Medicine III, Division of Nephrology and dialysis, Vienna
Rigshospitalet, Department of Nephrology, Copenhagen
Leiden University Medical Center, Department of Nephrology, Leiden
UZ Leuven, Leuven
Odense University Hospital, Medical Nephrology, Department Y, Odense
Medical University Innsbruck, Dept of Internal Medicine IV (Nephrology and Hypertension), Innsbruck
Med Uni Graz / LKH-UNIV Klinikum Graz, Klinische Abteilung fuer Nephrologie, Graz
Aarhus University Hospital, Renal Medicine and Clinical Medicine, Aarhus N
Charité Department of Nephrology and Intensive Care, Berlin
Všeobecná fakultní nemocnice v Praze, Prague
University Hospital of Marseille, Nephrology - Renal transplantation service, Marseille
Karolinska University Hospital, Huddinge
IRCCS Policlinico San Martino University Hospital, Department of Internal Medicine, Division of Nephrology, Genova
University Hospital Hamburg-Eppendorf, III Department of Medicine and Nephrology, Hamburg
John Hopkins Medical Institution, Baltimore
Skåne University Hospital, Department of Nephrology, Lund
ASST degli Spedali Civili di Brescia - SC Nefrologia, Brescia
Hôpital Rangueil, CHU de Toulouse, Department of Nephrology and Organ transplantation, Toulouse
CHU Grenoble Alpes - Michallon Hospital, Nephrology, Hemodialysis, Apheresis and Kidney Transplantation, Grenoble
IRCCS S. Orsola - Malpighi University Hospital - Nephrology, Dialysis and Transplantation Unit (pav 15), Bologna
The Ohio State University Wexner Medical Center, Columbus
CHU de Nantes, Hôtel-Dieu, Le service de néphrologie et immunologie clinique, Nantes
Uniklinik Koeln-Klinik II fuer Innere Medizin, Cologne
Uniklinik RWTH Aachen, Aachen
University of Minnesota Health Clinical Research Unit, Minneapolis
Linköping University Hospital, Linköping
CHU Lille. Nephrology, dialysis transplantation, Lille
Tenon Hospital, Renal intensive care unit, Paris
CHU de Rouen, Department of Nephrology,Transplantation, and Hemodialysis, Bois-Guillaume
LMU Klinikum, Medical Clinic IV / Department of Nephrology, Munich
UCLA Medical Center Plaza, Los Angeles
Universitaetsklinikum Erlangen - Medizinische Klinik 4, Erlangen
Brigham and Women's Hospital, Boston
UNC Kidney Center/Division of Nephrology & Hypertension, Chapel Hill
Nouvel Hôpital Civil (University Hospital of Strasbourg), Strasbourg
CHU Bordeaux, Hôpital Pellegrin, Service nephrologie, transplantation, dialyse, aphereses, Bordeaux
Carl-Gustav-Carus University Hospital, Medizinische Klinik III, Nephrologie, Dresden
Department of Renal Medicine, Cork University Hospital, Cork
University Medical Center Groningen, Division of Nephrology, Groningen
Radboudumc, Nijmegen
University Hospital Vall d'Hebron, Barcelona
Hospital Clinic de Barcelona, Barcelona
Uppsala University Hospital, Department of Medical Sciences, Renal Medicine, Uppsala
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Dept. of Vasculitis, Cambridge
Royal Infirmary of Edinburgh, Department of Renal Medicine, Edinburgh
University College London, Royal Free Hospital, Department of Renal Medicine, London
Hammersmith Hospital, Renal medicine and centre for inflammatory diseases, London
Manchester University Hospitals NHS Foundation Trust, Manchester
Lead Sponsor
Hansa Biopharma AB
INDUSTRY