Silymarin's Advantage on Graft Effectiveness (NCT06801886) | Clinical Trial Compass
By InvitationPhase 3
Silymarin's Advantage on Graft Effectiveness
Slovakia130 participantsStarted 2020-01-07
Plain-language summary
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.
Who can participate
Sex
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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%)
* Histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.