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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: EBV Infections, Kidney Transplant

In brief

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.

Key facts

Study ID

NCT07368153

Run by

University Hospital, Basel, Switzerland

People needed

9

Starts

2026-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Vasectomised partner
• Condom with spermicide
• Sexual abstinence, in line with the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• If male, participants must be prepared to use reliable barrier method contraception and a second method such as spermicide for the duration of the study unless surgically sterile.

You may not qualify if…

• 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.
• 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).
• Have taken an IMP within the last 3 months.
• Unwilling or unable to provide fully informed consent.
• Unwilling or unable to comply with study procedures.

Where it is running

• University Hospital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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