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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04877288 | A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications | PHASE3 | RECRUITING | 102 | — | — | Jul 21, 2021 | Jun 30, 2034 | Feb 3, 2026 | 38 | United States, Argentina +8 |
| Arm | Type | Description |
|---|---|---|
| Arm 1: Conversion from a CNI- to belatacept-based regimen after a period of overlap | EXPERIMENTAL | Conversion followed by tapering and discontinuation of the calcineurin inhibitor (CNI) |
| Arm 2: Continue calcineurin inhibitor-based regimen | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Belatacept | BIOLOGICAL | Specified dose on specified days |
| Tacrolimus | DRUG | Specified dose on specified days |
| Cyclosporine A | DRUG | Specified dose on specified days |
| Mycophenolate Mofetil | DRUG | Specified dose on specified days |
| Enteric Coated Mycophenolate Sodium | DRUG | Specified dose on specified days |
| Corticosteroids | DRUG | Specified dose on Specified days |
Inclusion Criteria: * Male and female adolescents 12 to less than 18 years of age * Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment * Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (...