CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 230 enrolled
Drug / intervention
Belatacept +3 moredrug
Likely dose
Belatacept intravenous; cyclosporine oral; mycophenolate mofetil oral; corticosteroids (methylprednisolone 500 mg IV day 1, 250 mg IV day 2; prednisone 100 mg orally day 3, 50 mg orally day 4, with subsequent taper)AI-extracted
Key inclusion· 1
  • ✓First kidney transplant recipient
Key exclusion· 19
  • ✕High-risk patients including those with prior renal transplant, panel reactive antibody >20%, or investigator-assessed higher rejection risk
  • ✕HLA-identical donor-recipient pairs
  • ✕Cold ischemia time >36 hours for donor kidney
  • ✕Positive for hepatitis C antibody, hepatitis B surface antigen, or HIV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00035555
NCT00035555Phase 2Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted May 6, 2002·Updated Jan 13, 2014

In Brief

A Phase 2 clinical trial evaluating Belatacept, Cyclosporine, and 2 other interventions for Graft Rejection and 2 related conditions. Completed, enrolled 230 participants across 12 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Rejection, Kidney Transplantation, Renal Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2002
Enrollment StartMar 1, 2001
Primary CompletionJan 1, 2004
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 24.2 years ago

Interventions

Belataceptdrug

Solution, intravenous

Cyclosporinedrug

Oral, capsule

Mycophenolate mofetil (MMF)drug

Oral, capsule

Corticosteroidsdrug

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