A Multicenter, Open-Label, Factorial Design, Randomized Controlled Study to Explore the Efficacy and Safety of Finerenone and Empagliflozin, Alone or in Combination, in Delaying Renal Function Progression in High-Risk CKD Patients After Radical Nephrectomy for Renal Cell Carcinoma
The goal of this clinical trial is to evaluate whether Finerenone and Empagliflozin, either alone or in combination, can delay the progression of renal function decline in patients at high risk for chronic kidney disease (CKD) following radical nephrectomy for renal cell carcinoma (RCC). It will also assess the safety of these treatments.The main questions it aims to answer are: 1. Does Finerenone and Empagliflozin, alone or in combination, slow the progression of renal function decline in high-risk CKD patients after RCC surgery? 2. What are the safety profiles of Finerenone and Empagliflozin in this patient population? Researchers will compare the treatment groups (Finerenone and Empagliflozin) to a blank control group (no drug) to determine if the treatments effectively delay renal function decline. Participants will: 1. Take either Finerenone and Empagliflozin (alone or in combination) or a blank control every day for 1 years. 2. Visit the clinic once every 3 months for checkups and tests. 3. Track their eGFR and other kidney function markers regularly. 4. Keep a diary to record any adverse events or changes in their health condition during the study.
• 1、Voluntary participation in the study and signing of the informed consent form, with the ability to comply with the study or follow-up procedures.
• 2、Age ≥ 18 years (at the time of signing the informed consent form), regardless of sex.
• 3、Patients with renal tumors (T1-T2) who are scheduled to undergo radical nephrectomy; no specific surgical procedure requirements.
• 4、Normal imaging of the healthy kidney at screening. 5、csCKD score ≥ 7 (moderate risk: 7-8 points; high risk: 9-10 points). 6、Preoperative difference in renal function of \<10% (healthy kidney function - affected kidney function).
• 7、Serum potassium ≤ 5.0 mmol/L. 8、Urinary albumin-to-creatinine ratio (UACR) \< 30 mg/g (3 mg/mmol). 9、ECOG performance status score of 0-2. 10、Normal cardiovascular, pulmonary, and liver function. 11、Women of non-reproductive potential are not required to undergo pregnancy testing or provide consent for appropriate contraceptive use. Non-reproductive potential is defined as women who have undergone hysterectomy, bilateral salpingectomy, oophorectomy, or are postmenopausal (with no other medical reasons for amenorrhea for 12 months).
• 12、Women of reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment, and must agree to use appropriate contraception during the study and for 8 weeks after the last dose of study intervention. Appropriate contraception is defined as an intrauterine device (IUD) or physical barriers (e.g., condoms)