NCT06801886Enrolling by invitationPhase 3
Silymarin's Advantage on Graft Effectiveness
Effect of Silymarin Supplementation on Graft Function and Early Post-transplant Complications
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 24 Jan 2025
- Start date
- 7 Jan 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University Hospital, Martin
- NCT number
- NCT06801886
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 130
- From 7 Jan 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multi-organ transplant recipients
- Patients taking medications with significant interactions with silymarin:
- Anticoagulants, Cytochrome P450 enzyme modulators
Other illness
- Active infectious complications at the time of transplantation: HIV, Active hepatitis B or C, Active cytomegalovirus (CMV) infection
- 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)
- Known allergy or hypersensitivity to silymarin or milk thistle
- Psychiatric conditions that may interfere with study compliance
- History of non-compliance with medical treatment
- Patients with known genetic disorders affecting drug metabolism
Lab values
- Patients with known liver disease: Cirrhosis, Active hepatitis, ALT or AST \> 2.5 times the upper limit of normal
- Uncontrolled diabetes mellitus (HbA1c \> 8.5%)
Other
- Recipients of ABO-incompatible or highly sensitized transplants
- Current or recent (within 30 days) participation in another clinical trial
- Pregnancy or planned pregnancy during the study period
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.