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Enrolling by Invitation

NCT Number: NCT06801886

Silymarin's Advantage on Graft Effectiveness

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.

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Key information

Conditions

Posttransplant Diabetes Mellitus Acute Graft Rejection Antibody Mediated Rejection of Kidney Transplant Arterial Hypertension, Chronic Kidney Disease Biopsy Proven Acute Rejection Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Martin

Martin, 036 01, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silymarine supplementation

Drug

900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment.

Placebo supplementation

Other

Placebo supplementation during the early post-transplant period (30 days) under standard treatment

Primary outcomes

  1. eGFR improvement

    Time frame: 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.

  2. Inicidence of biopsy proven acute rejection

    Time frame: 6 months

    Investigators assume - by supplementing silymarine the incidence of BPAR diagnosed by 3rd month protocolar biopsy, will be lower.

Secondary outcomes

  1. Incidence of PTDM

    Time frame: 6 months

    Investigators asssume by supplementing silymarine, the incidence of PTDM diagnosed according to 2024 guidelines will be lower in observed period.

  2. Incidence of dyslipidemia

    Time frame: 6 months

    Investigators asssume by supplementing silymarine, the incidence of hypercholesterolemia or dyslipidemia will be lower in observed period.

  3. Improved graft function in participatns with delayed graft function

    Time frame: 6 months

    Investigators assume that in the group of patients with DGF, those supplemented with silymarine will have better eGFR and graft function during the observed period.

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Official study title

Effect of Silymarin Supplementation on Graft Function and Early Post-transplant Complications

Acronym: SAGE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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