NCT06801886

Silymarin's Advantage on Graft Effectiveness

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

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University Hospital, Martin · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Silymarine supplementation	900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment.
OTHER	Placebo Supplementation	Placebo supplementation during the early post-transplant period (30 days) under standard treatment

Timeline

• Start date: 2020-01-07
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-01-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Slovakia