Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

PHASE2CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

March 31, 2001

Primary Completion Date

January 31, 2004

Study Completion Date

July 31, 2012

Conditions
Graft RejectionKidney TransplantationRenal Transplantation
Interventions
DRUG

Belatacept

Solution, intravenous

DRUG

Cyclosporine

Oral, capsule

DRUG

Mycophenolate mofetil (MMF)

Oral, capsule

DRUG

Corticosteroids

Corticosteroids given daily, orally or intravenously (IV). Day of transplant (Day 1): methylprednisolone, 500 mg, given IV on arrival in operating room; Day 2: methylprednisolone, 250 mg, given IV once daily; Day 3: prednisone, 100 mg, given orally once daily; Day 4: prednisone, 50 mg, given orally once daily; Days 5 through 30: prednisone, 25 mg, given orally once daily; Days 31-44: prednisone, 22.5 mg, given orally once daily; Days 45-58: prednisone, 20 mg, given orally once daily

Trial Locations (12)

19104

Univ. of Pennsylvania, Philadelphia

21205

Johns Hopkins University, Baltimore

29425

Medical Univ. of South Carolina, Charleston

30322

Emory Univ. School of Medicine, Atlanta

55905

Mayo Clinic, Rochester

75246

Baylor Univ. Medical Center, Dallas

94143-0001

Univ. of Calif. - San Francisco, San Francisco

02114

Massachusetts General Hospital, Boston

68198-1002

Univ. of Nebraska Medical Center, Omaha

07039

Saint Barnabas Medical Center, Livingston

10029-6574

Mount Sinai Medical Center, New York

53792-7375

Univ. of Wisconsin, Madison

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY