This clinical study will evaluate the safety and tolerability of an IDO-1 inhibitor in patients receiving a kidney transplant. The study includes individuals who have not previously been infected with Epstein-Barr virus (EBV) and who receive a kidney from a donor with prior EBV infection.
Participants will receive the IDO-1 inhibitor or placebo in addition to standard medical care and will be monitored for side effects and other safety-related outcomes throughout the study.
Willing and able to provide informed consent
Male or female aged ≥18 years
EBV seronegative at the time of renal transplant
Hormonal contraception associated with inhibition of ovulation
EBV seropositivity at the time of transplant
Participants with any form of cancer within the last 12 months, or patients continuing to receive chemo or immunotherapy within the last 12 months.
Participants with a history of PTLD
Other active systemic infections requiring treatment prior to and at the time of baseline. Prophylactic agents are permitted.
Parallel
indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor
DrugStudy 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
DrugA 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.
Incidence of adverse events
Incidence of serious adverse events
Number of participants experiencing adverse events
Number of participants experiencing clinically significant changes in safety assessments
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.
Changes in EBV viral load
Assessment EBV viral load in the event of a primary EBV infection
Changes in EBV viral dynamics
Assessment of EBV viral dynamics in the event of a primary EBV infection
Exploratory metabolomic analysis
including parameters related to the kynurenine pathway
Exploratory analysis peripheral blood mononuclear cells (PBMCs)
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University Hospital, Basel, Switzerland
Lead sponsor
Hornet Therapeutics.
Collaborator