Acute Graft Rejection, Antibody Mediated Rejection of Kidney Transplant, Arterial Hypertension, Chronic Kidney Disease, Biopsy Proven Acute Rejection, Posttransplant Diabetes Mellitus
Conditions
Keywords
silymarin, biopsy proven acute rejection, dnDSA, PTDM, protocolar biopsy, kidney transplantation
Brief 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.
Interventions
DRUGSilymarine supplementation
900 mg of silymarin supplementation daily during the early post-transplant period, (for 30 days) under standard treatment.
OTHERPlacebo Supplementation
Placebo supplementation during the early post-transplant period (30 days) under standard treatment
Sponsors
University Hospital, Martin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inicidence of biopsy proven acute rejection | 6 months | Investigators assume - by supplementing silymarine the incidence of BPAR diagnosed by 3rd month protocolar biopsy, will be lower. |
| eGFR improvement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PTDM | 6 months | Investigators asssume by supplementing silymarine, the incidence of PTDM diagnosed according to 2024 guidelines will be lower in observed period. |
| Incidence of dyslipidemia | 6 months | Investigators asssume by supplementing silymarine, the incidence of hypercholesterolemia or dyslipidemia will be lower in observed period. |
| Improved graft function in participatns with delayed graft function | 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. |
Countries
Slovakia
Outcome results
None listed