Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Neg… (NCT07368153) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors
Switzerland9 participantsStarted 2026-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide informed consent
✓. Male or female aged ≥18 years
✓. EBV seronegative at the time of renal transplant
✓. If women of child-bearing potential (WOCBP), participants must have a negative serum pregnancy test at screening and inclusion, and must be willing to use a highly effective method of birth control for the duration of the study. Acceptable methods of contraception:
✓. Hormonal contraception associated with inhibition of ovulation
✓. Intrauterine device (IUD)
✓. Intrauterine hormone-releasing system (IUS)
✓. Bilateral tubal occlusion
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of adverse events
Timeframe: up to 12 weeks post-treatment
2
Incidence of serious adverse events
Timeframe: up to 12 weeks post-treatment
3
Number of participants experiencing adverse events
Timeframe: up to 12 weeks post-treatment
4
Number of participants experiencing clinically significant changes in safety assessments
✕. Other active systemic infections requiring treatment prior to and at the time of baseline. Prophylactic agents are permitted.
✕. CYP3A4 and CYP2C28 Inhibitors and Inducers (List may be found in Appendix 1)
✕. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 x ULN
✕. Any condition for which, in the opinion of the investigator, the treatment or participation in the study may pose a health risk to the participant
✕. Planned or active participation in any other study with an investigational medicinal product (IMP).