Kidney transplant recipients with significant proteinuria SGLT2 inhibitor, Empagliflozin, proteinuria, kidney transplant
Conditions
Interventions
Empagliflozin 10mg per oral once daily,Matching placebo 1 capsule per oral once daily
Active Comparator Drug,Placebo Comparator Drug
Empagliflozin,Placebo
Sponsors
Division of Nephrology, King Chulalongkorn Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Kidney transplantation more than 6 months, 2.Age more than 18 year old, 3.Significant proteinuria Urine 24-hour protein more than 300 mg per day or Urine 24-hour albumin more than 200 mg per day or Urine protein to creatinine ratio more than 0.3 g per gCr or Urine albuminuria to creatinine ratio more than 200 mg per gCr, 4. eGFR (CKD-EPI) more than 20 mL per min per 1.73m2 and stable kidney function, 5. No immunosuppressive regimen adjustment in 3 months
Exclusion criteria
Exclusion criteria: 1. Active local or systemic infection, 2. Asymptomatic bacteriuria, 3. Recurrent UTI, 4. Acute rejection or have been treated within 3 months, 5. Type 1 diabetes mellitus, 6. Poor controlled diabetic mellitus, 7. Treated with SGLT-2 inhibitor within 8 weeks or history of SGLT-2 inhibitor intolerance, 8. Hepatic impairment, 9. Pregnancy or breast feeding, 10. Multiorgan transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine protein at 6 months after end of the intervention Urine protein creatinine index (UPCI), urine albumin creatinine ratio (UACR), 24 hour urine protein and albumin | — |
Secondary
| Measure | Time frame |
|---|---|
| estimated glomerular filtration rate (eGFR) decline at 6 months after end of the intervention estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI),Body weight change at 6 months after end of the intervention body weight,Blood pressure change at 6 months after end of the intervention office blood pressure,Blood sugar change at 6 months after end of the intervention Fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c),Lipid profile at 6 months after end of the intervention Lipid profile,Immunosuppressive dose at 6 months after end of the intervention Concentration to dose ratio,Adverse effect Along 6 months of study period Events of adverse effect | — |
Countries
Thailand
Contacts
Public ContactChanyanuch Rakpithayanon
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed