Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After … (NCT06818305) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: A Multicenter RCT
Stopped: The patient enrollment rate is proceeding too slowly
China10 participantsStarted 2025-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Preoperative eGFR \< 60 mL/min/1.73m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
. eGFR of the healthy kidney \< 30 mL/min/1.73m².
. Type 1 diabetes (T1D) or diabetic ketoacidosis.
. Pregnant or breastfeeding women.
. Patients with a desire to conceive during the study period or within 2 months after the study; male patients planning to conceive or donate sperm during the study period or within 3 months after the study.
. Body mass index (BMI) \< 18.5 kg/m² or \> 30 kg/m².
. Previous or concurrent participation in another clinical study (≤30 days before randomization).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of CKD stage 3b (eGFR < 45 mL/min/1.73m²) at 1 year post-surgery