Can two diabetes drugs save kidneys after cancer surgery?
NCT ID NCT06818305
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looked at whether two drugs, finerenone and empagliflozin, can slow kidney function decline in people at high risk for chronic kidney disease after having a kidney removed for cancer. Ten participants took one or both drugs or no drug for a year. The trial was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Finerenone and Empagliflozin (drugs)
- What this could lead to
- If successful, this could point toward a way to slow kidney function loss in patients who had a kidney removed due to cancer.
- What could go wrong
- This is a very small, early-phase study (only 10 participants) that was terminated, so results are limited. The drugs may not work better than standard care and carry risks like high potassium, low blood pressure, or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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10 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * Patients who meet any of the following conditions: 1. Preoperative eGFR \< 60 mL/min/1.73m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 2. eGFR of the healthy kidney \< 30 mL/min/1.73m². 3. Type 1 diabetes (T1D) or diabetic ketoacidosis. 4. Pregnant or breastfeeding women. 5. 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. 6. Body mass index (BMI) \< 18.5 kg/m² or \> 30 kg/m². 7. Previous or concurrent participation in another clinical study (≤30 days before randomization). 8. Communication disorders preventing full understanding or cooperation, or poor compliance. * Patients with the following medical or surgical history: 1. Urological structural abnormalities or unresolved functional abnormalities (e.g., duplicated kidney, polycystic kidney, horseshoe kidney, solitary kidney, renal artery stenosis, urinary tract obstruction, kidney stones, benign prostatic hyperplasia, prostatitis, or previous kidney surgery, etc.), long-term catheterization, etc. 2. History of or planned kidney replacement therapy (dialysis or kidney transplant) within 12 weeks or kidney transplant planned within 12 months. 3. Uncontrolled blood glucose: HbA1c ≥ 12%. 4. Uncontrolled blood pressure: Initial or follow-up seated systolic blood pressure (SBP) ≥ 180 mmHg or seated diastolic blood pressure (DBP) ≥ 110 mmHg, or symptomatic hypotension and/or systolic blood pressure \< 90 mmHg, or clinically judged hypovolemic patients. 5. Previous radiation therapy or ablation therapy to the healthy kidney or other surgical procedures. 6. History of heart failure (NYHA Class III-IV) or hospitalization due to fluid retention. 7. Clinical history of cerebrovascular disease (transient ischemic attack or stroke) or coronary artery disease (hospitalization for myocardial infarction or unstable angina, new-onset angina, or coronary angiography showing stenosis, coronary artery revascularization) within the last 6 months. 8. History of pulmonary hypertension, pulmonary fibrosis, or any lung condition requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema). 9. Severe peripheral edema or facial edema within 4 weeks of screening, requiring diuretic treatment, or history of myxedema. 10. Liver function impairment, with any of the following: history of hepatic encephalopathy, esophageal varices, portal vein shunt surgery, severe liver dysfunction (Child-Pugh Class C), ALT or AST \> 3 times the upper limit of normal (ULN), or total bilirubin \> 2 times the ULN at screening. 11. Primary adrenal insufficiency (Addison's disease). 12. Recurrent urinary tract infections within the past 6 months. 13. Organ or bone marrow transplant history. 14. History of malignancy, except for those with: cured or in remission for ≥5 years, or radically excised basal cell carcinoma, squamous cell carcinoma, or any in situ carcinoma at any site. 15. Received cytotoxic drugs, immunosuppressive therapy, or other immunotherapy for primary or secondary kidney disease within the last 6 months. 16. Hematocrit ≤ 30%. 17. Conditions that may significantly affect drug absorption, distribution, metabolism, or excretion, including but not limited to: 1) active inflammatory bowel disease in the last 6 months; 2) history of gastric surgery (e.g., gastrectomy, gastrointestinal anastomosis, or bowel resection); 3) history of gastrointestinal ulcers and/or gastrointestinal or rectal bleeding in the last 6 months; 4) history of pancreatic injury or pancreatitis in the last 6 months. 18. Other complex medical conditions that may interfere with the study behavior or increase risks, such as organ failure, immunodeficiency diseases or HIV-positive status, viral hepatitis, cognitive disorders, or severe physical or mental illnesses. 19. Any disease with a life expectancy of less than 12 months. 20. Known allergy to the study drug or any drugs with a similar chemical structure or excipients. Note: Finerenone contains lactose; patients with galactose intolerance or malabsorption, or lactase deficiency are contraindicated. * Current or past use of the following medications: 1. Currently using potassium-sparing diuretics (e.g., amiloride, triamterene), other mineralocorticoid receptor antagonists (e.g., eplerenone, esaxerenone, spironolactone, canrenone), and unable to stop the medication ≥ 4 weeks before screening. 2. Strong CYP3A4 inhibitors or inducers (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, naftifine, or grapefruit/grapefruit juice), and unable to stop at least 7 days before randomization. 3. Currently receiving systemic treatment for malignancy. 4. History of drug or alcohol abuse within the last 12 months. 5. Received Empagliflozin treatment within 8 weeks prior to dosing or known intolerance to Empagliflozin. 6. Received Finerenone treatment within 12 months prior to dosing. 7. Kidney transplant patients or those on high-dose steroids or immunosuppressive therapy (e.g., systemic lupus erythematosus, ANCA-associated vasculitis, glomerulonephritis, nephrotic syndrome).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing
Nanjing, Jiangsu, 210000, China
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Other studies related to the condition(s) this trial covers.
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