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

NCT06818305 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Finerenone (BAY 94-8862)

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).

DRUG

Empagliflozin 10 mg

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

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Jinling Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06818305 on ClinicalTrials.gov