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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06126380 | Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients | PHASE2 | ENROLLING BY_INVITATION | 132 | — | — | Oct 25, 2023 | Dec 1, 2029 | Dec 10, 2025 | 43 | United States, Australia +6 |
| NCT05983770 | Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation | PHASE2 | COMPLETED | 127 | — | — | Aug 30, 2023 | Sep 25, 2025 | Oct 29, 2025 | 43 | United States, Australia +5 |
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
| Arm | Type | Description |
|---|---|---|
| AT-1501 | EXPERIMENTAL | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | ACTIVE_COMPARATOR | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
| Investigative | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Comparator | ACTIVE_COMPARATOR | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
| Name | Type | Description |
|---|---|---|
| AT-1501 | DRUG | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | DRUG | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
Inclusion Criteria: * Successfully completed qualifying Parent study, where entry into the OLE was offered; * Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent; * Agree not to participate in...