EBV InfectionsPhase 2IDEPNCT07368153
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
A Phase 2 study testing indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor in people with EBV Infections and Kidney Transplant, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EBV Infections, Kidney Transplant
- What is being tested?
- indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 20 Aug 2026to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Not yet recruiting
University Hospital Basel
Basel, 4031
Matthias Diebold, PD Dr. med., +41 61 328 64 22, matthias.diebold@usb.ch
Pietro Cippà, Prof.
- Recruiting
University Hospital Bern
Bern, Canton of Bern, 3010
Daniel Sidler, Prof. Dr. med., (0)31 664 04 10 ext. 0041, daniel.sidler@insel.ch
- Not yet recruiting
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Lausanne, 1011
Manuel Oriol, Prof. Dr. med., (0)21 314 1026 ext. 0041, oriol.Manuel@chuv.ch
- Not yet recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Nicolas Müller, Prof. Dr. med., (0)44 255 33 22 ext. 0041, Nicolas.Mueller@usz.ch
About this study
Official title: A Randomised, Controlled, Double-blind Study to Evaluate the 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.
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.
Read the detailed description
This clinical study is being conducted to evaluate the safety and tolerability of an IDO-1 inhibitor in patients receiving a kidney transplant. The study population includes individuals who are Epstein-Barr virus (EBV) seronegative and receive a kidney from an EBV-seropositive donor, a group at increased risk for EBV-related complications following transplantation.
Kidney transplantation requires substantial immunosuppression to maintain graft function. While necessary, this immunosuppression increases susceptibility to infections, including EBV, which may lead to serious clinical consequences in immunocompromised individuals.
In this study, participants will receive the IDO-1 inhibitor or placebo in addition to standard-of-care immunosuppressive therapy. Study treatment will be initiated prior to kidney transplantation or on the day of transplantation, depending on donor availability, and will be administered for a defined treatment period, followed by a safety follow-up phase.
The primary objective of the study is to assess the safety and tolerability of the IDO-1 inhibitor in kidney transplant recipients, including the incidence of adverse events and clinically relevant laboratory abnormalities.
- Conditions
- EBV Infections, Kidney Transplant
- Being tested
- indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor, placebo
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitorDrug
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.
placeboDrug
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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: up to 12 weeks post-treatment
Incidence of serious adverse events
Measured: up to 12 weeks post-treatment
Number of participants experiencing adverse events
Measured: 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.
Measured: up to 12 weeks post-treatment
Secondary outcomes (4)
Changes in EBV viral load
Assessment EBV viral load in the event of a primary EBV infection
Measured: up to 12 weeks post-treatment
Changes in EBV viral dynamics
Assessment of EBV viral dynamics in the event of a primary EBV infection
Measured: up to 12 weeks post-treatment
Exploratory metabolomic analysis
including parameters related to the kynurenine pathway
Measured: up to 12 weeks post-treatment
Exploratory analysis peripheral blood mononuclear cells (PBMCs)
Measured: up to 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start20 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Hornet Therapeutics.
- Responsible party
- Sponsor
- Investigators
- Matthias Diebold, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368153
- Sponsor's protocol ID
- 2025-02366; ub24hess
- Other IDs
- 2025
- Acronym
- IDEP
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-blind Study to Evaluate the 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.
- ClinicalTrials.gov ID
- NCT07368153
- Acronym / sponsor ID
- IDEP / 2025-02366; ub24hess
- Conditions
- EBV Infections, Kidney Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Hornet Therapeutics.
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical study is being conducted to evaluate the safety and tolerability of an IDO-1 inhibitor in patients receiving a kidney transplant. The study population includes individuals who are Epstein-Barr virus (EBV) seronegative and receive a kidney from an EBV-seropositive donor, a group at increased risk for EBV-related complications following transplantation.
Kidney transplantation requires substantial immunosuppression to maintain graft function. While necessary, this immunosuppression increases susceptibility to infections, including EBV, which may lead to serious clinical consequences in immunocompromised individuals.
In this study, participants will receive the IDO-1 inhibitor or placebo in addition to standard-of-care immunosuppressive therapy. Study treatment will be initiated prior to kidney transplantation or on the day of transplantation, depending on donor availability, and will be administered for a defined treatment period, followed by a safety follow-up phase.
The primary objective of the study is to assess the safety and tolerability of the IDO-1 inhibitor in kidney transplant recipients, including the incidence of adverse events and clinically relevant laboratory abnormalities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitorStudy 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. | Drug | Treatment |
| placeboA 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. | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: up to 12 weeks post-treatment
Incidence of serious adverse events
Time frame: up to 12 weeks post-treatment
Number of participants experiencing adverse events
Time frame: up to 12 weeks post-treatment
Number of participants experiencing clinically significant changes in safety assessments
Time frame: up to 12 weeks post-treatment
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.
4 secondary outcomes
Changes in EBV viral load
Time frame: up to 12 weeks post-treatment
Changes in EBV viral dynamics
Time frame: up to 12 weeks post-treatment
Exploratory metabolomic analysis
Time frame: up to 12 weeks post-treatment
Exploratory analysis peripheral blood mononuclear cells (PBMCs)
Time frame: up to 12 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for EBV Infections
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingPhase 3
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Diebold principal investigator
University Hospital, Basel, Switzerland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor in people with EBV Infections and Kidney Transplant, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Ernesto Cippà, Prof. (+41 61 32 84848, pietro.cippa@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: up to 12 weeks post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.