proteinuria after kidney transplantation
Conditions
Interventions
Experimental group:Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + finelidone (10 or 20mg orally once a day)
control group:Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + Dapagliflozin (10 or 20mg orally once a day)
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Adult kidney transplant patients (>=18 years old) 2. The diagnosis and screening of chronic kidney disease (CKD) after kidney transplantation meet at least one of the following criteria: a. Persistent high proteinuria (UACR of 30-300 mg/g, more than 2 of 3 early morning urination samples) and estimated glomerular filtration rate (eGFR) of 25-60ml/min/1.73m^2 (CKD EPI) and the presence of diabetic retinopathy. b. Persistent extremely high albuminuria (UACR>=300mg/g, more than 2 of 3 early morning urination samples) and eGFR<=25 mL /min/1.73m^2 (CKD EPI) 3. Previous treatments with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor block (ARB) are as follows: A. At least 4 weeks prior to the run-in visit, subjects should receive ACEI or ARB or a combination of both b. At the beginning of the run-in visit, subjects were receiving only ACEI or ARB or a combination of both. c. At least 4 weeks prior to the screening visit, subjects should be treated with only the maximum tolerated labeled dose (but not less than the minimum labeled dose) of ACEI or ARB, preferably without adjustment of dose or drug selectivity or any other antihypertensive or antiglycemic therapy. 4. Serum potassium <=4.8mmol/L during running-in and screening. 5. Voluntarily sign informed consent
Exclusion criteria
Exclusion criteria: 1. Kidney transplant recipients have a history of retransplantation, multiple kidney transplants, and transplantation of other organs and tissues. 2. Known significant non-diabetic nephropathy, including clinically relevant renal artery stenosis. 3. Uncontrolled arterial hypertension (i.e. mean sitting systolic blood pressure (SBP) >=170mmHg at presentation, sitting diastolic blood pressure (DBP) >=110mmHg, or mean sitting SBP=160mmHg, sitting DBP>= 100mmHg at screening) 4. In patients with type I diabetes, the hemoglobin a1C (HbA1c) is >12%. 5. Uncontrolled hypotension; The mean SBP at run-in visit or screening visit was <90mmHg 6. Chronic heart failure clinically diagnosed at run-in visit with decreased ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] Grade II-IV) (Level 1A recommendation for salocorticoid receptor antagonist MRA) 7. Hospitalization for stroke, transient ischemic attack, acute coronary syndrome, or worsening heart failure within 30 days prior to screening 8. Hemokalium was higher than 5.5mmol/L within 12 weeks after treatment due to acute renal failure 9. Patients with malignant tumors or other metabolic disorders have a history of allergic diseases or allergies 10. Severe liver damage 11 Pregnant or lactating women 12. Severe infectious diseases 13. There are other circumstances that the investigator deems inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| creatinine;24-hour urinary protein quantity;eGFR; | — |
Countries
China
Contacts
Public ContactZeng Li
Shanghai Changhai Hospital
Outcome results
None listed