Silymarin's Advantage on Graft Effectiveness (SAGE)

University Hospital, Martin

Status and phase: Invitation-only; Phase 3

Conditions: Acute Graft Rejection; Antibody Mediated Rejection of Kidney Transplant; Biopsy Proven Acute Rejection; Arterial Hypertension, Chronic Kidney Disease; Posttransplant Diabetes Mellitus

Treatments: Drug: Silymarine supplementation; Other: Placebo Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06801886

TNO_UNM

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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%)
• History of non-compliance with medical treatment
• Patients with known genetic disorders affecting drug metabolism

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients suplemented with placebo

Treatment:

Other: Placebo Supplementation

Silymarin

Experimental group

Description:

Patients suplemented with silymarin

Treatment:

Drug: Silymarine supplementation