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Clinical efficacy and safety of finerenone combined with dapagliflozin in the treatment of diabetic kidney disease: a randomized controlled trial

Clinical efficacy and safety of finerenone combined with dapagliflozin in the treatment of diabetic kidney disease: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104080
Enrollment
Unknown
Registered
2025-06-10
Start date
2024-01-18
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Interventions

Experimental group:Based on the maximum tolerated ACEI or ARB treatment, the initial dose of finerenone tablets was 10mg once daily. After 1 month, the dose was increased from 10 to 20mg if the serum
control group:Based on the maximum tolerable dose of ACEI or ARB treatment, the initial dose of Dapagliflozin tablets is 5 mg/day, which can be increased to 10 mg/day according to the blood glucose co

Sponsors

The First Affiliated Hospital of Shihezi University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old and diagnosed with type 2 diabetes; 2. Diagnosis of DKD according to the Guidelines for the Prevention and Treatment of Diabetic Nephropathy in China (2021 Edition); 3. Glomerular filtration rate (eGFR) >=30mL/(min·1.73 m^2) 4.UACR >= 30mg/g; 5. Treatment with ACEi or ARB at the maximum tolerated dose for = four weeks 6. No use of SGLT2 inhibitors and MRA in the past 3 months 7. Those who are aware of this study, express their willingness to participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Non-diabetic kidney disease; 2. EF value=160/100mmHg; 4. Glycosylated hemoglobin > = 10% 5. Kidney atrophy 6. Patients with recent acute and chronic infection, gastrointestinal bleeding, malignant tumors and abnormal liver function 7. Adrenal insufficiency 8. Hyperkalemia

Design outcomes

Primary

MeasureTime frame
Urinary protein excretion rate;Rate of decline in glomerular filtration rate;UACR;

Secondary

MeasureTime frame
Serum interleukin-6;monocyte chemotactic protein-1(MCP-1);TNF-a;EF%;

Countries

China

Contacts

Public ContactGuorui Zhang

The First Affiliated Hospital of Shihezi University

1282573280@qq.com+86 137 7921 2653

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026