Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Belatacept LI (less intensive)
Belatacept LI · 1 trial · 2 indications
Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.
Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.
Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.
| Arm | Type | Description |
|---|---|---|
| Cyclosporine (CsA) | ACTIVE_COMPARATOR | - |
| Belatacept LI (less intensive) | EXPERIMENTAL | - |
| Belatacept MI (more intensive) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cyclosporine (CsA) | DRUG | 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) |
| Belatacept LI (less intensive) | DRUG | 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) |
| Belatacept MI (more intensive) | DRUG | 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) |
Inclusion Criteria: * The subject is a recipient of a living donor or deceased donor kidney transplant. * Male or Female, 18 or older Exclusion Criteria: * First time recipient, PRA \>- 50% or for retransplantation PRA \>- 30%. * If retransplantation, previous graft loss cannot be due to acute re...
Belatacept LI is being developed for use in kidney transplantation. It is intended as an immunosuppressive therapy for patients receiving a kidney transplant, including those with chronic kidney failure. The Phase 3 BENEFIT trial evaluated it as first-line immunosuppression in this setting.
Belatacept LI targets CD80 and CD86. It is an inhibitor of these costimulatory molecules, which are involved in T-cell activation. By binding to CD80 and CD86, belatacept LI blocks the costimulation signal required for full T-cell activation, thereby providing immunosuppression.
Belatacept LI is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical program evaluating belatacept LI in kidney transplantation.
Belatacept LI is in Phase 3 clinical development. The Phase 3 BENEFIT trial has been completed. Belatacept LI is investigational and has not been approved by the FDA for any indication.
Belatacept LI has been studied in the Phase 3 BENEFIT trial, registered as NCT00256750. The trial enrolled 738 participants with kidney transplantation or chronic kidney failure. It was randomized, active-controlled, and completed. The study took place in multiple countries including the United States, Argentina, Australia, and several European and Asian nations.
Yes, Belatacept LI is also known as Belatacept LI (less intensive). The abbreviation LI stands for less intensive, referring to a less intensive dosing regimen of belatacept. Both names refer to the same investigational drug being developed by Bristol-Myers Squibb for kidney transplantation.