Who is sponsoring NCT00035555?

NCT00035555 is sponsored by Bristol-Myers Squibb.

What condition does NCT00035555 study?

NCT00035555 studies Graft Rejection, Kidney Transplantation, Renal Transplantation.

What drugs are being tested in NCT00035555?

Interventions: Belatacept, Cyclosporine, Mycophenolate mofetil (MMF), Corticosteroids.

What is the status of NCT00035555?

NCT00035555 is currently COMPLETED.

Last reviewed 2013-11-27 · How we verify

Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 (Belatacept) as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients

NCT00035555 Phase 2 COMPLETED Results posted

The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better kidney function and blood pressure, fewer lipid problems, less diabetes mellitus).

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	COMPLETED
Enrolment	230
Start date	2001-03
Completion	2012-07

Conditions

Graft Rejection
Kidney Transplantation
Renal Transplantation

Interventions

Belatacept
Cyclosporine
Mycophenolate mofetil (MMF)
Corticosteroids

Primary outcomes

Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) — By Month 6 posttransplant (From Day 1 to Month 6)
No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.

Countries

United States