The Effects of Empagliflozin on Proteinuria in Kidney Transplantation Patients: A Randomized Controlled Trial

Phase 3

Recruiting

• Conditions: Kidney transplant recipients with significant proteinuria; SGLT2 inhibitor, Empagliflozin, proteinuria, kidney transplant

• Registration Number: TCTR20240406005
• Lead Sponsor: Division of Nephrology, King Chulalongkorn Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-06
• Last Update Posted: 19 August 2024
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rine 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 Outcome Measures

Name	Time	Method
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