Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

PHASE3CompletedINTERVENTIONAL
Enrollment

738

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

April 30, 2015

Conditions
Kidney TransplantationChronic Kidney Failure
Interventions
DRUG

Cyclosporine (CsA)

tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)

DRUG

Belatacept LI (less intensive)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

DRUG

Belatacept MI (more intensive)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Trial Locations (105)

1090

Local Institution, Vienna

1900

Local Institution, La Plata

2000

Local Institution, Rosario

2050

Local Institution, Camperdown

2145

Local Institution, Westmead

3000

Local Institution, Leuven

3010

Local Institution, Bern

3052

Local Institution, Parkville

4001

Local Institution, Durban

5000

Local Institution, Adelaide

6020

Local Institution, Innsbuck

7925

Local Institution, Observatory

8091

Local Institution, Zurich

9000

Local Institution, Ghent

10029

Recanati/Miller Transplantation Institute, New York

10032

Columbia University College Of Physicians & Surgeons, New York

13033

Local Institution, Campinas

13353

Local Institution, Berlin

14080

Local Institution, Distrito Federal

Local Institution, Mexico City

14642

University Of Rochester Medical Center, Rochester

19102

Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery, Philadelphia

20000

Local Institution, Aguascalientes

20162

Local Institution, Milan

21041

Local Institution, Rio de Janeiro / Rj

22031

Inova Transplant Center, Fairfax

27232

Vanderbilt University Medical Center, Nashville

27599

University Of North Carolina At Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

28040

Local Institution, Madrid

28203

Carolinas Medical Center, Charlotte

29010

Local Institution, Málaga

29425

Musc, Charleston

29609

Local Institution, Brest

30309

Piedmont Hospital, Atlanta

30322

Emory University Hospital, Atlanta

30625

Local Institution, Hanover

30912

Medical College Of Georgia, Augusta

31054

Local Institution, Toulouse

33076

Local Institution, Bordeaux

35128

Local Institution, Padua

35294

University Of Alabama At Birmingham, Birmingham

38043

Local Institution, Grenoble

40536

University Of Kentucky, Lexington

44093

Local Institution, Nantes

45122

Local Institution, Essen

48202

Henry Ford Hospital, Transplant Institute, Detriot

49100

Local Institution, Petah Tikva

52242

University Of Iowa Hospitals And Clinics, Iowa City

53226

Froedtert Memorial Lutheran Hospital, Milwaukee

53792

University Of Wisconsin, Madison

55455

University Of Minnesota, Minneapolis

60637

University Of Chicago Hospitals, Chicago

62448

Local Institution, Cuernavaca

63110

Washington University School Of Medicine, St Louis

64460

Local Institution, Monterrey

75015

Local Institution, Paris

75246

Baylor University Medical Center, Dallas

78240

Local Institution, San Luis Potosí City

80045

University Of Colorado Health Sciences Center, Aurora

90035

Local Institution, Porto Alegre

Local Institution, Porto Alegre/rs

90048

Cedars Sinai Medical Center, Los Angeles

91054

Local Institution, Erlangen

92123

California Institute Of Renal Research, San Diego

92354

Loma Linda University Medical Center-Transplantation Institu, Loma Linda

94000

Local Institution, Créteil

94143

University Of California San Francisco Medical Center, San Francisco

98104

Swedish Medical Center, Seattle

99204

Sacred Heart Medical Ctr Providence Medical Research Ctr, Spokane

110076

Local Institution, New Delhi

160012

Local Institution, Chandigarh

226000

Local Institution, Lucknow

380016

Local Institution, Gujarat

380052

Local Institution, Ahmedabad

387001

Local Institution, Nadiād

400016

Local Institution, Mumbai

682304

Local Institution, Kochi

06520

Yale University School Of Medicine-Yale New Haven Hospital, New Haven

04102

Maine Tranplant Program, Portland

01107

Western New England Renal & Transplant Associates, Pc, Springfield

05401

Fletcher Allen Health Care, Burlington

C1155APP

Local Institution, Buenos Aires

C1425APQ

Local Institution, Capital Federal

X5016KEH

Local Institution, Cordoba, Crd

S3000EPV

Local Institution, Santa Fe

04038

Local Institution, Sao Paulo/sp

05403

Local Institution, São Paulo

T6G 2S2

Local Institution, Edmonton

B3H 2Y9

Local Institution, Halifax

H1T 2M4

Local Institution, Montreal

H2L 2W5

Local Institution, Montreal

H3A 1A1

Local Institution, Montreal

S7M 0Z9

Local Institution, Saskatoon

140 21

Local Institution, Prague

H-6720

Local Institution, Szeged

400 026

Local Institution, Mumbai

600 006

Local Institution, Chennai

00168

Local Institution, Roma

60-479

Local Institution, Poznan

70-111

Local Institution, Szczecin

0002

Local Institution, Pretoria

08907

Local Institution, Barcelona

SE-413 45

Local Institution, Gothenburg

07059

Local Institution, Antalya

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY