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

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT07368153
Phase
PHASE2
Status
Recruiting
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Conditions

  • EBV Infections
  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

First listed
Jan 26, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment
  • Placebo Comparator: Placebo

Primary Outcome Measure

Incidence of adverse events [ Time Frame: up to 12 weeks post-treatment ]

Central Contacts

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