Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

PHASE3TerminatedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

November 6, 2017

Primary Completion Date

January 20, 2021

Study Completion Date

January 20, 2021

Conditions
Antibody-mediated Rejection
Interventions
DRUG

C1-esterase inhibitor

C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution

DRUG

Placebo

Excipients of C1-INH plus albumin

Trial Locations (26)

2300

Leiden University Medical Center, Leiden

3000

Universitair Ziekenhuis Gasthuisberg, Leuven

10016

NYU, New York

10032

Columbia University, New York

10117

Charite Berline, Berlin

31059

CHU Rangueil, Toulouse

33000

CHU de Bordeaux. Hôpital Pellegrin, Bordeaux

35233

University of Alabama Hospital (at Birmingham), Birmingham

37232

Vanderbilt University, Nashville

38043

CHU de Grenoble - Hôpital Michalon, Grenoble

55905

Mayo Clinic (Rochester), Rochester

59000

Centre Regional Hospitalier Universitaire de Lille, Lille

60612

University of Illinois Chicago, Chicago

69003

Hospital Edouard Herriot Lyon, Lyon

75010

Hopital saint Louis Paris, Paris

75743

Necker Hospital, Paris

77030

Houston Methodist, Houston

85054

Mayo Clinic Arizona, Phoenix

94115

California Pacific, San Francisco

06520

Yale New Haven Hospital, New Haven

02115

Brigham & Women's, Boston

07039

St. Barnabas Medical Center, Livingston

53705-2281

University of Wisconsin, Madison

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

SE19RT

Guy's Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY