Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TNX-1500 · 2 trials · 5 indications
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
| Arm | Type | Description |
|---|---|---|
| Kidney Transplant Recipient | EXPERIMENTAL | - |
| Arm 1: TNX-1500 3 mg/kg | EXPERIMENTAL | - |
| Arm 2: TNX-1500 10 mg/kg | EXPERIMENTAL | - |
| Arm 3: TNX-1500 30 mg/kg | EXPERIMENTAL | - |
| Arm 4: Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TNX-1500 | DRUG | This is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients. |
| Kidney Transplant | PROCEDURE | Kidney Transplant |
| Placebo: USP 0.9% sterile saline for injection | DRUG | The placebo comparator arm (Arm 4) |
| Keyhole Limpet Hemocyanin (KLH) | BIOLOGICAL | KLH is not the primary therapeutic drug being tested. Instead, it is an "immunogenic T-cell dependent antigen" used as a challenge tool to assess the pharmacological and immunosuppressant effects of TNX-1500 |
Inclusion Criteria: 1. Male or female subjects ≥18 to 75 years of age. 2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital. 3. Recipient of an ABO-compatible, non-human leu...