Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00114777 | Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant | PHASE3 | COMPLETED | 595 | — | — | Feb 1, 2005 | Sep 1, 2014 | Jul 7, 2017 | 79 | United States, Argentina +17 |
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...