Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for kidney transplantation. It is studied as a first-line immunosuppression treatment to prevent organ rejection in patients with chronic kidney failure undergoing kidney transplantation. The drug is currently in Phase 3 clinical development.
Belatacept LI is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in kidney transplant patients.
Belatacept LI is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for use in kidney transplantation.
Belatacept LI has one completed Phase 3 clinical trial, identified as NCT00256750, titled "Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)." This trial enrolled 738 participants with kidney transplantation and chronic kidney failure across multiple countries.
Belatacept LI is a formulation of belatacept, a selective T-cell costimulation blocker. The "LI" designation may refer to a specific formulation or route of administration. The drug is being studied for its potential to provide immunosuppression in kidney transplant recipients.