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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
130
900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment.
Placebo supplementation during the early post-transplant period (30 days) under standard treatment
University Hospital Martin
Martin, Slovakia
eGFR improvement
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.
Time frame: 3 months
Inicidence of biopsy proven acute rejection
Investigators assume - by supplementing silymarine the incidence of BPAR diagnosed by 3rd month protocolar biopsy, will be lower.
Time frame: 6 months
Incidence of PTDM
Investigators asssume by supplementing silymarine, the incidence of PTDM diagnosed according to 2024 guidelines will be lower in observed period.
Time frame: 6 months
Incidence of dyslipidemia
Investigators asssume by supplementing silymarine, the incidence of hypercholesterolemia or dyslipidemia will be lower in observed period.
Time frame: 6 months
Improved graft function in participatns with delayed graft function
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.
Time frame: 6 months
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