Silymarin's Advantage on Graft Effectiveness (SAGE)

March 25, 2025 updated by: Matej Vnucak, University Hospital, Martin

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Martin, Slovakia, 036 01
        • University hospital Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients suplemented with placebo
Other: Placebo Supplementation
Placebo supplementation during the early post-transplant period (30 days) under standard treatment
Experimental: Silymarin
Patients suplemented with silymarin
Drug: Silymarine supplementation
900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Incidence of dyslipidemia
Time Frame: 6 months
Investigators asssume by supplementing silymarine, the incidence of hypercholesterolemia or dyslipidemia will be lower in observed period.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Martin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNO_UNM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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