| Trial ID: | L1681 |
| Source ID: | NCT06801886
|
| Associated Drug: |
Silymarine Supplementation
|
| Title: |
Silymarin's Advantage on Graft Effectiveness
|
| Acronym: |
SAGE
|
| Status: |
ENROLLING_BY_INVITATION
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Posttransplant Diabetes Mellitus|Acute Graft Rejection|Biopsy Proven Acute Rejection|Antibody Mediated Rejection of Kidney Transplant|Arterial Hypertension, Chronic Kidney Disease
|
| Interventions: |
DRUG: Silymarine supplementation|OTHER: Placebo Supplementation
|
| Outcome Measures: |
Primary: 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., 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., 6 months | Secondary: Incidence of PTDM, 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, 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, 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
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Martin
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
130
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: PREVENTION
|
| Start Date: |
2020-01-07
|
| Completion Date: |
2025-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-30
|
| Locations: |
University Hospital Martin, Martin, 036 01, Slovakia
|
| URL: |
https://clinicaltrials.gov/show/NCT06801886
|
