None listed
Conditions
Interventions
Drug : Experimental group: Envlo 0.3mg PO once daily (18 months)
Placebo group: Placebo 0.3mg PO once daily (18 months)
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older, but younger than 80 years. 2. Patients who are more than 12 months but less than 60 months post kidney transplantation. 3. eGFR (CKD-EPI formula) =30 mL/min/1.73m2. 4. Patients currently taking a standard triple immunosuppressive regimen [CNI inhibitor (tacrolimus or cyclosporine) - antimetabolite (mycophenolate mofetil or mycophenolic acid) - steroid (prednisolone, methylprednisolone, or deflazacort combination)]. 5. Subjects who have voluntarily given written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes. 2. Patients with diabetic ketoacidosis. 3. Patients who have received organ transplants other than kidneys. 4. Diagnosed with lupus nephritis or ANCA-associated nephritis. 5. Patients who have had a transplant rejection episode (antibody-mediated or T-cell mediated rejection) within 1 year prior to screening. 6. Patients with donor-specific antibody titers exceeding a median fluorescence index (MFI) of 3000 within 1 year prior to screening. 7. Cardiovascular events (heart failure, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass surgery) within 3 months prior to screening or elective percutaneous coronary intervention within 1 month prior to screening. 8. Subjects with moderate to severe liver disease. 9. Uncontrolled diabetes (HbA1c =12%). 10. Patients who have taken an SGLT2 inhibitor within 8 weeks prior to screening. 11. Patients with a hypersensitivity reaction to an SGLT2 inhibitor. 12. Patients with a history of genital infections within 12 months prior to screening. 13. Patients with a history of urinary tract infections twice or more within 12 months prior to screening. 14. Pregnant or breastfeeding patients, or women of childbearing potential not using adequate contraception. 15. Individuals who do not agree to use an effective method of contraception (condoms with spermicide, vasectomy, tubal ligation, vaginal diaphragm with spermicide, IUD, contraceptive sponge with spermicide, hormonal contraception) during the clinical trial. 16. Patients who have previously been allocated treatment in this clinical trial. 17. Concurrent participation in another interventional clinical trial (e.g., Phase 1-3 clinical trial) or administration of investigational medicinal products within 30 days prior to randomization. 18. Other patients who are deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average rate of change measured by the overall slope of the estimated glomerular filtration rate (eGFR) from baseline to the 18th month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Inter-group comparison of the urine protein-to-creatinine ratio (UPCR) at 18 months compared to baseline;Inter-group comparison of HbA1c at 18 months compared to baseline;Inter-group comparison of blood glucose levels at 18 months compared to baseline;Inter-group comparison of new-onset diabetes after transplantation;Number of participants with treatment-emergent adverse event (TEAE), treatment-emergent serious adverse event (TESAE), and adverse event of special interest (AESI) ; Chronic eGFR slope from the 3rd month to the planned end of the treatment period; Time to renal failure or a sustained =30% decrease in eGFR from baseline for at least 4 weeks; Change in eGFR from baseline to one month after the end of treatment (treatment discontinuation); Number of subjects with at least a 30% reduction in UPCR from baseline at 6 months; Incidence and time to onset of renal replacement therapy (dialysis); Transplanted kidney survival rate (death-censored graft loss, death with a functioning graft).;Time to cardiovascular mortality; Time to first hospitalization for heart failure or emergency department visit for heart failure;Time to first cardiovascular event (CV death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic attack, hospitalization for heart failure, or emergency heart failure visit);Time to hospitalization for cardiovascular cause;Time to onset of all-cause mortality;Time to hospitalization for any cause;Acute or chronic rejection confirmed by kidney biopsy;Inter-group comparison of weight changes during the treatment period | — |
Countries
Korea, Republic of
Contacts
Public ContactChan-Young Jung
Asan Medical Center
Outcome results
None listed