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

NCT07368153 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-02366; ub24hess
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

EBV Infections; Kidney Transplant

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  up to 12 weeks post-treatment

• Incidence of serious adverse events

  up to 12 weeks post-treatment

• Number of participants experiencing adverse events

  up to 12 weeks post-treatment

• 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.

  up to 12 weeks post-treatment

Secondary Outcomes (4)

• Changes in EBV viral load

  up to 12 weeks post-treatment

• Changes in EBV viral dynamics

  up to 12 weeks post-treatment

• Exploratory metabolomic analysis

  up to 12 weeks post-treatment

• Exploratory analysis peripheral blood mononuclear cells (PBMCs)

  up to 12 weeks post-treatment

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

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.

Placebo

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Hornet Therapeutics.: collaborator
• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Matthias Diebold

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Ernesto Cippà, Prof.

CONTACT

+41 61 32 84848; pietro.cippa@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A randomised, controlled, double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)