IDO-1 inhibitor safety in EBV-seronegative kidney transplant recipients getting EBV-positive donor kidneys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2 study, patients who are EBV seronegative and receiving a kidney from an EBV-seropositive donor will be randomized to receive either an IDO-1 inhibitor or placebo in addition to standard immunosuppression. The main goal is to assess safety and tolerability, including adverse events and lab abnormalities, during treatment and a subsequent safety follow-up. The intervention may begin before or at the time of transplant and continues for a defined period. Outcomes focus on safety with secondary observations related to graft function and infection risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide informed consent
2. Male or female aged ≥18 years
3. EBV seronegative at the time of renal transplant
4. 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:

   1. Hormonal contraception associated with inhibition of ovulation
   2. Intrauterine device (IUD)
   3. Intrauterine hormone-releasing system (IUS)
   4. Bilateral tubal occlusion
   5. Vasectomised partner
   6. Condom with spermicide
   7. 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.
5. 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.

Exclusion Criteria:

1. EBV seropositivity at the time of transplant
2. Participants with any form of cancer within the last 12 months, or patients continuing to receive chemo or immunotherapy within the last 12 months.
3. Participants with a history of PTLD
4. Other active systemic infections requiring treatment prior to and at the time of baseline. Prophylactic agents are permitted.
5. CYP3A4 and CYP2C28 Inhibitors and Inducers (List may be found in Appendix 1)
6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 x ULN
7. 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
8. Planned or active participation in any other study with an investigational medicinal product (IMP).
9. Have taken an IMP within the last 3 months.
10. Unwilling or unable to provide fully informed consent.
11. Unwilling or unable to comply with study procedures.

Where it's running

• University Hospital Bern
  Bern, Canton of Bern, Switzerland Recruiting
• University Hospital Zurich
  Zurich, Canton of Zurich, Switzerland Not yet recruiting
• Centre hospitalier universitaire vaudois (CHUV)
  Lausanne, Lausanne, Switzerland Not yet recruiting
• University Hospital Basel
  Basel, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Matthias Diebold — University Hospital, Basel, Switzerland
• Study coordinator: Pietro Ernesto Cippà, Prof.
• Email: pietro.cippa@usb.ch
• Phone: +41 61 32 84848

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)

  This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.

  Recruiting Vivalyx GmbH · Rotterdam · NCT07792317

• How Propofol and Sevoflurane Affect miRNA in Living Kidney Donors

  This study tests whether using propofol or sevoflurane during donor nephrectomy changes levels of miRNAs in living kidney donors.

  Recruiting University of Gaziantep · Gaziantep, Sahinbey · NCT07760402

• Effects of general vs spinal-epidural anesthesia on kidney transplant biomarkers

  This study tests whether sevoflurane general anesthesia or combined spinal-epidural anesthesia changes markers of cellular stress and protective peptides in adults undergoing kidney transplantation.

  Recruiting University of Gaziantep · Gaziantep, State/Province · NCT07678073

• How kidney transplant patients feel about using artificial intelligence in medicine

  This international survey asks adults who have had a kidney transplant how they feel about AI tools that predict graft loss and what it might mean for their daily care.

  Recruiting at 2 sites Paris Translational Research Center for Organ Transplantation · Paris, Île-de-France Region and 1 other locations · NCT07600541

• Personalized therapeutic stories for children after kidney transplant.

  We will test whether clinician-supervised AI can create age-appropriate, personalized therapeutic stories for children aged 5–12 who have received a kidney transplant and their families.

  Recruiting Paris Translational Research Center for Organ Transplantation · Paris, Île-de-France Region · NCT07532382

• Treating blood vessel problems after a kidney transplant

  This effort will try catheter-based angioplasty and advanced imaging to see if they help kidney transplant recipients with graft dysfunction or stubborn high blood pressure from possible transplant blood‑vessel problems.

  Recruiting at 3 sites University of Aarhus · Aarhus and 2 other locations · NCT07531966

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.