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Also known as indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor
indoleamine 2, 3-dioxygenase 1 inhibitor · 1 trial · 2 indications
Safety assessments include vital signs (pulse rate, blood pressure, and body temperature), 12-lead electrocardiogram (ECG), and laboratory evaluations (haematology and serum/plasma biochemistry), assessed up to and including 12 weeks post-treatment.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor | DRUG | Study treatment will be initiated one day prior to kidney transplantation or, for recipients of cadaveric donor organs, on the day of transplantation, and will be administered at a dose of 200 mg once daily for a total duration of 28 days, followed by a safety follow-up phase. |
| placebo | DRUG | A matching placebo will be administered once daily, initiated one day prior to kidney transplantation or, for recipients of cadaveric donor organs, on the day of transplantation, for a total duration of 28 days, followed by a safety follow-up phase. |
Inclusion Criteria: 1. Willing and able to provide informed consent 2. Male or female aged ≥18 years 3. EBV seronegative at the time of renal transplant 4. If women of child-bearing potential (WOCBP), participants must have a negative serum pregnancy test at screening and inclusion, and must be wil...
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