Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CsA
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 used in renal transplantation, where it is given to help prevent rejection of a transplanted kidney. It is a small molecule immunosuppressant developed by Bristol-Myers Squibb Company. The Phase 3 trial NCT00114777 studied it in renal transplant recipients across 18 countries.
Cyclosporin A targets PPIA, also known as cyclophilin A. It acts as a modulator of this target. By binding PPIA, Cyclosporin A inhibits calcineurin signaling in T cells, which suppresses the immune response that would otherwise attack a transplanted kidney.
Cyclosporin A is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 3 renal transplantation trial NCT00114777, which enrolled 595 participants.
Cyclosporin A is in Phase 3 development for renal transplantation. The Phase 3 trial NCT00114777 has been completed, and it was an active-controlled, randomized study with 595 participants. Cyclosporin A is an investigational small molecule immunosuppressant.
Cyclosporin A has been studied in the Phase 3 trial NCT00114777, titled Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant. The trial enrolled 595 participants, was randomized and active-controlled, and has been completed. It included sites in the United States, Europe, Latin America, and other regions.