Effect of Silymarin Supplementation on Graft Function and Early Post-transplant Complications
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- eGFR improvement
研究概览
简要总结
The study examines the impact of silymarin supplementation during the early post-transplant period, administering 900 g daily for 30 days under standard treatment. Subsequently, the investigators investigate its impact on graft function, as measured by eGFR (CKD-EPI equation), UACR or UPCR, the development of dnDSA, rejection changes, and histological changes in the 3-month biopsy protocol. At the same time, investigators will investigate the effect of silymarin on metabolic complications-PTDM, DLP, disorders of calcium-phosphate metabolism, and arterial hypertension in the post-transplant period-in comparison with the placebo group. At the same time, investigators will investigate the safety and tolerance of silymarin.
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
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second kidney transplant recipient
- •Deceased or living donor kidney transplant
- •Patients receiving standard immunosuppression regimen:
- •Tacrolimus or cyclosporine + Mycophenolate mofetil + Corticosteroids
- •Body Mass Index (BMI) 18-35 kg/m²
- •Willingness to provide informed consent
- •Ability to understand and comply with study procedures
- •Stable medical condition without significant comorbidities
排除标准
- •Multi-organ transplant recipients
- •Recipients of ABO-incompatible or highly sensitized transplants
- •Active infectious complications at the time of transplantation: HIV, Active hepatitis B or C, Active cytomegalovirus (CMV) infection
- •Patients with known liver disease: Cirrhosis, Active hepatitis, ALT or AST > 2.5 times the upper limit of normal
- •Significant cardiovascular disease: Recent myocardial infarction (within 6 months), Unstable angina, Severe heart failure (NYHA Class III or IV)
- •Malignancy within the past 5 years (except successfully treated non-melanoma skin cancer)
- •Current or recent (within 30 days) participation in another clinical trial
- •Pregnancy or planned pregnancy during the study period
- •Known allergy or hypersensitivity to silymarin or milk thistle
- •Patients taking medications with significant interactions with silymarin:
- •Anticoagulants, Cytochrome P450 enzyme modulators
- •Psychiatric conditions that may interfere with study compliance
- •Uncontrolled diabetes mellitus (HbA1c > 8.5%)
- •History of non-compliance with medical treatment
- •Patients with known genetic disorders affecting drug metabolism
研究组 & 干预措施
Placebo
Patients suplemented with placebo
干预措施: Placebo Supplementation (Other)
Silymarin
Patients suplemented with silymarin
干预措施: Silymarine supplementation (Drug)
结局指标
主要结局
eGFR improvement
时间窗: 3 months
Investigators estimate 1 month of silymarin supplementation may improve eGFR by 5 ml/min/1.73 m2 compared to palcebo at 3 months. Assuming a standard deviation of 10 ml/min/1.73 m2, a two-sided aplha of 0.005, and 80 % power, a sample size 64 participants per group is required.
Inicidence of biopsy proven acute rejection
时间窗: 6 months
Investigators assume - by supplementing silymarine the incidence of BPAR diagnosed by 3rd month protocolar biopsy, will be lower.
次要结局
- Incidence of PTDM(6 months)
- Incidence of dyslipidemia(6 months)
- Improved graft function in participatns with delayed graft function(6 months)
研究者
Matej Vnucak
ass.prof., MD, Ph.D.
University Hospital, Martin