Liver transplant. Liver transplant status
Conditions
Interventions
Intervention 1: Intervention group: a single empagliflozin 10 mg tablet daily, following the morning meal for a period of 24 weeks. Intervention 2: Control group: one placebo tablet daily, containing
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Liver transplant recipients aged between 18 and 65 years Stable renal function status, defined as a less than 20% change in serum creatinine level over the past two months eGFR greater than 20 mL/min/1.73 m² At least two months of continuous immunosuppressive therapy with tacrolimus or cyclosporine.
Exclusion criteria
Exclusion criteria: AST or ALT levels exceeding three times the upper limit of the normal range Total bilirubin levels exceeding two times the upper limit of the normal range A history of type 1 diabetes A history of autosomal dominant polycystic kidney disease An active urinary-genital infection A history of severe sensitivity to SGLT2i A history of simultaneous transplantation of another organ Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate. Timepoint: Before intervention and 4, 12 , 24 weeks after intervention. Method of measurement: Chronic Kidney Disease Epidemiology Collaboration formula.;Urinary albumin to creatinine ratio. Timepoint: Before intervention and 4, 12 , 24 weeks after intervention. Method of measurement: Laboratory test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prothrombin time (international normalized ratio). Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Laboratory test.;The incidence of cardiovascular events. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: History of ischemic heart diseases.;The incidence of neurological symptoms. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: History of hand tremors, headache, visual disturbance and seizures.;The necessity for hospitalization. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: History of hospitalization for any reason.;Graft rejection rate. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Biopsy-confirmed transplant rejection.;The rate of transplanted organ loss. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Patient's medical record.;Mortality rate. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Patient's medical record.;The incidence of urinary-genital infection. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: History of dysuria and frequency confirmed by the presence of bacteriuria or genital burning and itching confirmed by examination.;Body mass index. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Digital scale.;Blood pressure. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Medical pressure gauge.;Hemoglobin. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Laboratory test.;Hematocrit. Timepoint: Before the intervention and 4, 12, 24 weeks after the intervention. Method of measurement: Laborat | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Emad Molaei
Tehran University of Medical Sciences
Outcome results
None listed