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

Sponsor
Jinling Hospital, China
Study ID
NCT06818305
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Feb 2025
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Participants will receive finerenone.
  • Experimental: Empagliflozin
    Participants will receive empagliflozin.
  • Experimental: Combination therapy of Finerenone and Empagliflozin
    Participants will receive finerenone and empagliflozin.
  • No Intervention: Blank control group
    Participants did not receive medication.

Primary Outcome Measure

The incidence of CKD stage 3b (eGFR < 45 mL/min/1.73m²) at 1 year post-surgery [ Time Frame: 1 year after surgery ]

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