Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: A Multicenter RCT

NCT06818305 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2024DZKY-097-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.What are the safety profiles of Finerenone and Empagliflozin in this patient population?
3. 3.Take either Finerenone and Empagliflozin (alone or in combination) or a blank control every day for 1 years.
4. 4.Visit the clinic once every 3 months for checkups and tests.
5. 5.Track their eGFR and other kidney function markers regularly.
6. 6.Keep a diary to record any adverse events or changes in their health condition during the study.

Conditions

Renal Cell Carcinoma (Kidney Cancer); Renal Cell Carcinoma (RCC); Nephrectomy; Chronic Kidney Disease(CKD)

Keywords

Renal Cell Carcinoma; Radical Nephrectomy; Chronic Kidney Disease; Renal Functional Compensation; Finerenone; Empagliflozin; Renal Protection; Clinically Significant CKD; Randomized Controlled Trial; Mineralocorticoid Receptor Antagonist; CKD; RCC; MRA; csCKD; RCT

Outcome Measures

Primary Outcomes (1)

• The incidence of CKD stage 3b (eGFR < 45 mL/min/1.73m²) at 1 year post-surgery

  1 year after surgery

Secondary Outcomes (5)

• The safety and tolerability of Finerenone and Empagliflozin, alone or in combination

  Up to end of study visit (up to approximately 12 months)

• Renal function compensation rate 1 year after surgery

  1 year after surgery

• The change rate in the volume of the healthy kidney parenchyma at 1 year post-surgery

  1 year after surgery

• Rate of change of normal unit renal parenchymal function at 1 year after surgery

  1 year after surgery

• The incidence of UACR ≥ 30 mg/g at 1 year post-surgery.

  1 year after surgery

Study Arms (4)

Finerenone

EXPERIMENTAL

Participants will receive finerenone.

Drug: Finerenone (BAY 94-8862)

Empagliflozin

EXPERIMENTAL

Participants will receive empagliflozin.

Drug: Empagliflozin 10 mg

Combination therapy of Finerenone and Empagliflozin

EXPERIMENTAL

Participants will receive finerenone and empagliflozin.

Drug: Finerenone (BAY 94-8862); Drug: Empagliflozin 10 mg

Blank control group

NO INTERVENTION

Participants did not receive medication.

Interventions

Finerenone (BAY 94-8862) DRUG

Adjusting lifestyle and managing underlying conditions according to the "Chronic Kidney Disease Early Screening, Diagnosis, and Prevention Guidelines (2022 Edition)" + Finerenone (10mg/d or 20mg/d).

Combination therapy of Finerenone and Empagliflozin; Finerenone

Empagliflozin 10 mg DRUG

Adjusting lifestyle and managing underlying conditions according to the "Chronic Kidney Disease Early Screening, Diagnosis, and Prevention Guidelines (2022 Edition)" + Empagliflozin (10mg/d).

Combination therapy of Finerenone and Empagliflozin; Empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、Voluntary participation in the study and signing of the informed consent form, with the ability to comply with the study or follow-up procedures.
• 、Age ≥ 18 years (at the time of signing the informed consent form), regardless of sex.
• 、Patients with renal tumors (T1-T2) who are scheduled to undergo radical nephrectomy; no specific surgical procedure requirements.
• 、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).
• 、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).
• 、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)

You may not qualify if:

• Patients who meet any of the following conditions:
• 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).
• Communication disorders preventing full understanding or cooperation, or poor compliance.
• Patients with the following medical or surgical history:
• 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.
• History of or planned kidney replacement therapy (dialysis or kidney transplant) within 12 weeks or kidney transplant planned within 12 months.
• Uncontrolled blood glucose: HbA1c ≥ 12%.
• 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.
• Previous radiation therapy or ablation therapy to the healthy kidney or other surgical procedures.

Sponsors & Collaborators

• Jinling Hospital, China: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Renal Insufficiency, Chronic

Interventions

finerenone; empagliflozin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 10, 2025
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-02

Locations

CN (1)