A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant

PHASE3TerminatedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 20, 2016

Primary Completion Date

May 31, 2019

Study Completion Date

May 31, 2019

Conditions
Acute Antibody-Mediated Rejection (AMR)
Interventions
BIOLOGICAL

Cinryze®

Participants will receive 5000 Units of CINRYZE (50 millilitre \[mL\] of CINRYZE/ 50 mL of normal saline) on Day 1 and 2500 Units of CINRYZE (25 mL of CINRYZE/ 75 mL of normal saline) on Day 3, 5, 7, 9, 11, and 13 respectively.

DRUG

Placebo

Participants will receive 7 doses of matched placebo over 13 days of treatment.

Trial Locations (47)

8907

Hospital Universitari de Bellvitge, Barcelona

10029

Mount Sinai Hospital, New York

10032

Columbia University Medical Center, New York

10065

New York Presbyterian Hospital - Weill-Cornell, New York

10605

NYU Longone Medical Center, White Plains

15146

University of Pittsburgh Medical Center, Monroeville

19104

University of Pennsylvania Health System, Philadelphia

20057

MedStar Georgetown University Hospital, Washington D.C.

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

21201

University of Maryland Medical Center, Baltimore

21287

Johns Hopkins University, Baltimore

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30309

Piedmont Hospital, Atlanta

31059

Hôpital de Rangueil, Toulouse

32804

Florida Hospital Transplant Institute, Orlando

33136

Jackson Memorial Hospital, Miami

37204

Vanderbilt University Medical Center, Nashville

38043

CHU Michallon, Grenoble

43210

Ohio State University Medical Center, Columbus

44093

Hotel Dieu, Nantes

44195

Cleveland Clinic, Cleveland

45220

University of Cincinnati, Cincinnati

55414

University of Minnesota, Minneapolis

60611

Northwestern Memorial Hospital, Chicago

61449

Universitätsklinikum Frankfurt, Steinbach

63110

Washington University School of Medicine, St Louis

69120

Universität Heidelberg, Heidelberg

73112

INTEGRIS Nazih Zuhdi Transplant Institute, Oklahoma City

75010

Hôpital Saint Louis, Paris

75015

Groupe Hospitalier Necker Enfants Malades, Paris

76104

Baylor All Saints Medical Center, Fort Worth

77030

Houston Methodist Hospital, Houston

80045

University Of Colorado School Of Medicine, Aurora

84132

University of Utah Health Sciences Center, Salt Lake City

90024

Kidney Transplant Research Office at UCLA, Los Angeles

90033

Keck School of Medicine at USC, Los Angeles

94010

Hopital Henri Mondor, Créteil

94110

University of California San Francisco, San Francisco

94275

Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre

02115

Brigham and Womens Hospital, Boston

07039

Saint Barnabas Medical Center, Livingston

V6Z 2K5

Providence Health Care Research Institute, Vancouver

H4A 3J1

Royal Victoria Hospital, Montreal

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

3015 CE

Erasmus MC, Rotterdam

08916

Hospital Universitario Germans Trias i Pujol, Badalona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY