Experimental Group: Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + finelidone (10 or 20mg orally once a day)
Control (Standard treatment): Oral ACEI/ARB (e.g., valsartan capsules 80mg qd or 150mg qd) + Dapagliflozin (10 or 20mg orally once a day)
Study summary
The goal of this clinical trial is to learn if Finerenone works to treat proteinuria patients after kidney transplantation. It will also learn about the safety of Finerenone. The main questions it aims to answer are:
Does Finerenone lower the number of UACR values in kidney transplant recipients?? What medical problems do participants have when taking Finerenone? Researchers will compare Finerenone to Dapagliflozin to see if Finerenone works to treat proteinuria patients after kidney transplantation.
Eligibility
Sex
ALL
Min age
19 Years
Max age
65 Years
Healthy volunteers
No
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:
1. 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/1.73m2 (CKD EPI) and the presence of diabetic retinopathy.
2. Persistent extremely high albuminuria (UACR≥300mg/g, more than 2 of 3 early morning urination samples) and eGFR≤25 mL /min/1.73m2 (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:
* 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.
Primary outcome measure(s)
Urine Albumin-to-Creatinine Ratio — From enrollment to the end of treatment at 6 months"
creatinine — From enrollment to the end of treatment at 6 months"
Trial sites (1)
Facility
City
Region
Status
Changhai Hospital
Shanghai
Shanghai Municipality
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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