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
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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…