An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.

PHASE2CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

May 31, 2000

Primary Completion Date

April 30, 2003

Study Completion Date

June 30, 2005

Conditions
Cadaveric Donor Renal TransplantationAcute Renal Allograft RejectionInduction Therapy
Interventions
BIOLOGICAL

Thymoglobulin [Anti-thymocyte Globulin (rabbit)]

1.5 mg/kg per day, for a maximum of 5 doses

DRUG

Simulect (basliximab)

20 mg per day on 2 days

Trial Locations (28)

10595

Westchester Medical Center, Valhalla

14004

Hospital Reina Sofia, Córdoba

15212

Allegheny General Hospital, Pittsburgh

25000

Hopital Saint Jacques, Besançon

28041

Hospital Occe de Octubre, Madrid

28232

Carolinas Medical Center, Charlotte

30322

Emory University Hospital, Atlanta

30912

Medical College of Georgia, Augusta

32804

Florida Hospital Medical Center and Translife, Orlando

35296

University of Alabama, Birmingham

38043

Centre Hospitalier Universitaire, Grenoble

40536

University of Kentucky Medical Center, Lexington

48109

University of Michigan Hospital, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

54511

Hopital de Bradois, Cedex

59003

Hopital Edouard Herriot, Lyon

60612

Rush University Transplant Program, Chicago

77555

University of Texas Medical Branch, Galveston

90095

UCLA School of Medicine, Los Angeles

92151

Hopital Foch, Suresnes

94115

California Pacific Medical Center, San Francisco

06510

Yale University School of Medicine, New Haven

07039

St. Barnabas Medical Center, Livingston

12 91054

Unicersitat Erlangen-Numberg, Erlangen

52 20246

University Hospital Eppendorf, Hamburg

Unknown

Hospital de Cruces, Barakaldo

Freeman Hospital, Newcastle upon Tyne

08036

Hospital Clinico Universitario, Barcelona

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00235300 - An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients. | Biotech Hunter | Biotech Hunter