Clinical Trial

Silymarin's Advantage on Graft Effectiveness

Study acronym: SAGE
Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated March 30, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-24.
Trial Details
NCT Number NCT06801886
Lead Sponsor University Hospital, Martin
Conditions Posttransplant Diabetes Mellitus, Acute Graft Rejection, Biopsy Proven Acute Rejection, Antibody Mediated Rejection of Kidney Transplant, Arterial Hypertension, Chronic Kidney Disease
Enrollment 130 participants
Start Date 2020-01-07
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-30