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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Incidence of adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
A randomised, controlled, double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment
干预措施: indoleamine 2,3-dioxygenase 1 (IDO-1) inhibitor (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: up to 12 weeks post-treatment
Incidence of serious adverse events
时间窗: up to 12 weeks post-treatment
Number of participants experiencing adverse events
时间窗: up to 12 weeks post-treatment
Number of participants experiencing clinically significant changes in safety assessments
时间窗: 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.
次要结局
- 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)