Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Thymoglobulin · 2 trials · 2 indications
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with \>25% of parenchyma affected and moderate tubulitis with \>4 mononuclear cells/tubular cross section; IB: \>10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.
| Arm | Type | Description |
|---|---|---|
| Belatacept + Everolimus | EXPERIMENTAL | Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; belatacept (infusion) regimen of 10 mg/kg i.v. on Day 1, Weeks 1, 2, 4, 8 and 12 post transplant and then a maintenance dose of 5 mg/kg every 4 weeks after 12 weeks post transplant; everolimus (tablet) daily dosing at 3.0 mg/day, 2 divided doses, starting on Day 3 dosing adjusted based on blood sample tests; methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed) |
| Tacrolimus + Mycophenolate mofetil | EXPERIMENTAL | Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; tacrolimus (tablet) daily dosing beginning at 0.1 mg/kg/day, then adjusted based on blood sample tests; MMF (tablet) daily dosing between 0.5 to 2.0 g/day divided in 2 doses (up to 3 g/day if African Americans/Blacks); methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed) |
| belatacept, mycophenolate mofetil (MMF) | EXPERIMENTAL | thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF 1g twice daily(bis in die, BID) |
| belatacept, sirolimus | EXPERIMENTAL | thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months;sirolimus 5 mg/day on Day 1 (day of transplant)and continued through Day 2, dosing to be adjusted to keep pre-dose C0 levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until 12 months. |
| tacrolimus, MMF | OTHER | (IMPs as comparator regimen)thymoglobulin 1.5mg/kg for 4 days; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
| Name | Type | Description |
|---|---|---|
| Thymoglobulin | DRUG | - |
| Belatacept | DRUG | - |
| mycophenolate mofetil(MMF) | DRUG | - |
| Corticosteroids | DRUG | - |
| Everolimus(EVL) | DRUG | - |
| Tacrolimus(TAC) | DRUG | - |
| Sirolimus | DRUG | Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter |
| Tacrolimus | DRUG | The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial |
| Mycophenolate Mofetil (MMF) | DRUG | Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Men and women, aged 18 to 75 * Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+) * Diagnosed with end stage renal disease (ESRD) and schedule...
Thymoglobulin is an investigational small molecule being studied for disorders related to renal transplantation and kidney transplantation. It has been evaluated in Phase 2 clinical trials as part of immunosuppressive regimens to prevent organ rejection in patients undergoing kidney transplantation.
Thymoglobulin is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of the drug in kidney transplantation settings.
Thymoglobulin is in Phase 2 clinical development. It has completed Phase 2 trials, and it remains an investigational drug that has not been approved by regulatory authorities. Its development is focused on kidney transplantation-related conditions.
Thymoglobulin has been studied in two completed Phase 2 trials: NCT00455013, which evaluated a steroid-free regimen with belatacept in 93 subjects undergoing kidney transplantation, and NCT02137239, a regimen optimization study in 58 kidney transplant patients. Both trials are completed.
No, Thymoglobulin is not the same as belatacept. In the clinical trial NCT00455013, Thymoglobulin was used as part of a regimen that included belatacept (BMS-224818), but they are distinct drugs with different mechanisms of action.