Rescue of Nephrons With ALE.F02 (RENAL-F02)

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 7, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Glomerulonephritis Rapidly Progressive
Interventions
BIOLOGICAL

ALE.F02

ALE.F02 is an anti-Claudin-1 (CLDN1) monoclonal antibody (mAb) to selectively target the non-tight junctions (TJ), exposed form of CLDN1. CLDN1 is an integral component of the TJs between cells.

DRUG

Rituximab

Rituximab is a monoclonal antibody that targets cluster of differentiation antigen 20 (CD20), an antigen expressed on the surface of pre-B and mature B-lymphocytes

DRUG

GlucoCorticoid

Glucocorticoids are a class of corticosteroids, which are a class of steroid hormones that bind to the glucocorticoid receptor. Glucocorticoid effects may be broadly classified into two major categories: immunological and metabolic.

DRUG

Cyclophosphamid

Cyclophosphamid is a medication used as chemotherapy and to suppress the immune system

DRUG

Placebo

Drug product that will contain no active ingredient

DRUG

Immunosuppressive Agents

Immunosuppressants are drugs that prevent your immune system from attacking healthy cells and tissues by mistake.

Trial Locations (48)

1752

RECRUITING

Hôpital Fribourgeois-Freiburger Spital, Villars-sur-Glâne

3010

RECRUITING

Inselspital, Universitaetsspital Bern, Bern

5000

RECRUITING

Odense University Hospital, Odense

5404

RECRUITING

Kantonsspital Baden AG, Baden

8200

RECRUITING

Aarhus University Hospital, Aarhus

9000

RECRUITING

Aalborg University Hospital, Aalborg

RECRUITING

Kantonsspital St. Gallen, Sankt Gallen

10117

RECRUITING

Charite Universitaetsmedizin Berlin, Berlin

20132

RECRUITING

IRCCS Ospedale San Raffaele, Milan

23562

RECRUITING

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Lübeck

25198

RECRUITING

Hospital Universitari Arnau de Vilanova, Lleida

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

29001

RECRUITING

Hospital Regional Universitario de Malaga, Málaga

29200

RECRUITING

CHRU de Brest - Hopital de la Cavale Blanche, Brest

30625

RECRUITING

Medizinische Hochschule Hannover (MHH), Hanover

31000

RECRUITING

CHU de Nimes, Nîmes

31400

RECRUITING

CHU de Toulouse - Hopital Rangueil, Toulouse

33000

RECRUITING

CHU Bordeaux - Hopital Pellegrin, Bordeaux

38122

RECRUITING

APSS Ospedale Santa Chiara di Trento, Trento

38700

RECRUITING

CHU Grenoble-Alpes - Hopital Michallon, La Tronche

44000

RECRUITING

CHU de Nantes - Hotel-Dieu, Nantes

45147

RECRUITING

Universitaetsklinikum Essen, Essen

50134

RECRUITING

Azienda Ospedaliero-Universitaria Careggi, Florence

50931

RECRUITING

Universitaetsklinikum Koeln (AoeR), Cologne

59300

RECRUITING

Centre Hospitalier de Valenciennes, Valenciennes

62200

RECRUITING

Centre Hospitalier Boulogne sur Mer, Boulogne-sur-Mer

75013

RECRUITING

AP-HP Hopital Pitie-Salpetriere, Paris

75014

RECRUITING

AP-HP Hopital Cochin, Paris

80802

RECRUITING

Klinikum der Ludwig-Maximilians-Universitaet Muenchen, München

128 08

RECRUITING

Vseobecna fakultni nemocnice v Praze, Prague

140 21

RECRUITING

Institut klinicke a experimentalni mediciny, Prague

56 2100

RECRUITING

Rigshospitalet, Copenhagen

01307

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden, Dresden

04103

RECRUITING

Universitaetsklinikum Leipzig, Leipzig

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Rome

08025

RECRUITING

Fundacio Puigvert, Barcelona

08907

RECRUITING

Hospital Universitari de Bellvitge, Barcelona

581 85

RECRUITING

Linkoping University Hospital, Linköping

907 37

RECRUITING

University Hospital of Umea, Umeå

Unknown

RECRUITING

Ankara Etlik City Hospital, Ankara

RECRUITING

Marmara University Medical Faculty Hospital, Istanbul

RECRUITING

Kocaeli University Medical School - Internal Medicine - Nephrology, Kocaeli

RECRUITING

Erciyes University Faculty of Medicine, Melikgazi

B152GW

RECRUITING

Queen Elizabeth Hospital Birmingham, Birmingham

CB2 0QQ

RECRUITING

Cambridge University - Addenbrooke's Hospital, Cambridge

L78YE

RECRUITING

Royal Liverpool University Hospital, Liverpool

W21NY

RECRUITING

Imperial College Healthcare NHS Trust, London

PR2 9HT

RECRUITING

Royal Preston Hospital, Preston

Sponsors
All Listed Sponsors
lead

Alentis Therapeutics AG

INDUSTRY

NCT06047171 - Rescue of Nephrons With ALE.F02 (RENAL-F02) | Biotech Hunter | Biotech Hunter