Belatacept Early Steroid Withdrawal Trial
Summary
The study purpose is to determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin (rATG) induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant recipients. The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab induction, mycophenolate mofetil (MMF)/mycophenolic acid (MPA), and early glucocorticoid withdrawal (Group A) in renal transplant recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of graft loss, patient death, or reduced renal function at 12 months as compared to a tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and early glucocorticoid withdrawal in renal transplant recipients (Group C).
Timeline
- Start
- 2012-09
- Primary completion
- 2018-12
- Completion
- 2019-12
Publications
- Pyatt A, McGowan M, Tanaka R, Miyagawa B, Mizuno T, Shields AR, Christianson A, West-Thielke P, Leone JP, Woodle ES, Kaufman D, Wiseman A, Matas AJ, Vinks AA, Alloway RR. Belatacept Pharmacokinetic Analysis of Belatacept Early Steroid Withdrawal Trial (BEST) to Clinical Outcomes and Compared With Reported BENEFIT and BENEFIT-EXT Pharmacokinetic Analysis. Clin Transplant. 2025 Aug;39(8):e70172. doi: 10.1111/ctr.70172.
- Kaufman DB, Woodle ES, Shields AR, Leone J, Matas A, Wiseman A, West-Thielke P, Sa T, King EC, Alloway RR; BEST Study Group. Belatacept for Simultaneous Calcineurin Inhibitor and Chronic Corticosteroid Immunosuppression Avoidance: Two-Year Results of a Prospective, Randomized Multicenter Trial. Clin J Am Soc Nephrol. 2021 Sep;16(9):1387-1397. doi: 10.2215/CJN.13100820. Epub 2021 Jul 7.
- Castro-Rojas CM, Godarova A, Shi T, Hummel SA, Shields A, Tremblay S, Alloway RR, Jordan MB, Woodle ES, Hildeman DA. mTOR Inhibitor Therapy Diminishes Circulating CD8+ CD28- Effector Memory T Cells and Improves Allograft Inflammation in Belatacept-refractory Renal Allograft Rejection. Transplantation. 2020 May;104(5):1058-1069. doi: 10.1097/TP.0000000000002917.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Comparator | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Subject | rabbit anti-thymocyte globulin | Protein / enzyme biologic | 4 mg/kg | Intravenous |
| Subject | rabbit anti-thymocyte globulin | Protein / enzyme biologic | 6 mg/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 500 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 1500 mg | — |
| Background | Mycophenolate Sodium | Unknown | 720 mg | — |
| Background | Mycophenolate Sodium | Unknown | 1080 mg | — |
| Background | Prednisone | Other / unclassified | 60 mg | Oral |
Indications
No indication recorded.