Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cyclosporin A · 1 trial · 1 indication
Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.
GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.
| Arm | Type | Description |
|---|---|---|
| Cyclosporin A | ACTIVE_COMPARATOR | - |
| Belatacept Less Intensive Regimen (LI) | EXPERIMENTAL | - |
| Belatacept More Intensive Regimen (MI) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cyclosporin A | DRUG | tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months |
| Belatacept Less Intensive Regimen (LI) | 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 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months |
| Belatacept More Intensive Regimen (MI) | 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, 5 mg/kg every 4 weeks, q 4 weeks, 84 months |
Inclusion Criteria: * Subject is a first-time recipient of a kidney transplant from a deceased donor. * Specific donor criteria Exclusion Criteria: * Donor age \<10 years * Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.) * Subjects with a positive T-cell lymphoc...
Cyclosporin A is an investigational small molecule being studied for use in renal transplantation. It is currently in Phase 3 clinical development for this indication. The drug is being evaluated in patients undergoing renal transplant procedures as part of a clinical trial program.
Cyclosporin A is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this small molecule for the treatment of renal transplantation.
Cyclosporin A is in Phase 3 clinical development for renal transplantation. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development.
Cyclosporin A has one completed Phase 3 clinical trial registered under NCT00114777. This study, titled 'Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant,' enrolled 595 participants across multiple countries including the United States, Argentina, Australia, and several European nations.
Cyclosporin A is not the same as Belatacept. The clinical trial NCT00114777, which studies Cyclosporin A, is titled 'Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant.' This indicates the trial compares or evaluates both drugs, but they are distinct investigational agents.