| Trial ID: | L1435 |
| Source ID: | NCT06818305
|
| Associated Drug: |
Finerenone (Bay 94-8862)
|
| Title: |
Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: a Multicenter RCT
|
| Acronym: |
EmFin-Nx
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Cell Carcinoma (Kidney Cancer)|Renal Cell Carcinoma (RCC)|Nephrectomy|Chronic Kidney Disease(CKD)
|
| Interventions: |
DRUG: Finerenone (BAY 94-8862)|DRUG: Empagliflozin 10 mg
|
| Outcome Measures: |
Primary: The incidence of CKD stage 3b (eGFR < 45 mL/min/1.73m²) at 1 year post-surgery, 1 year after surgery | Secondary: The safety and tolerability of Finerenone and Empagliflozin, alone or in combination, The incidence of hyperkalemia、hypotension、Urinary system infection and hypoglycemia, 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
|
| Sponsor/Collaborators: |
Sponsor: Jinling Hospital, China | Collaborators: The Affiliated Hospital of Xuzhou Medical University|Qilu Hospital of Shandong University|Yantai Yuhuangding Hospital|The First Affiliated Hospital with Nanjing Medical University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01-01
|
| Completion Date: |
2027-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-10
|
| Locations: |
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Nanjing, Jiangsu, 210000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06818305
|
