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Effect of finerenone on urinary protein and inflammatory factors in type 2 diabetes mellitus patients with diabetic kidney disease

Study on the effect of finerenone on urinary protein and inflammatory factors in type 2 diabetes mellitus patients with diabetic kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094919
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Type 2 diabetes nephropathy

Interventions

control group :None

Sponsors

The First Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. For adult patients who meet the diagnostic criteria for diabetes nephropathy proposed in the Chinese Guidelines for the Prevention and Treatment of diabetes Nephropathy (2021), the diagnostic criteria are as follows: If DM is identified as the cause of kidney damage and other causes of CKD are excluded, at least one of the following conditions can be diagnosed as DKD. 1.1 Excluding interfering factors, in at least 2 out of 3 tests conducted within 3-6 months, the urinary albumin to creatinine ratio (UACR) should be = 30 mg/g or the 24-hour urinary albumin excretion rate (UAER) should be = 30 mg/24 h (= 20 µ g/min); 1.2 Estimated glomerular filtration rate (eGFR)<60 ml · min ?¹ · (1.73 m ²) ?¹ for more than 3 months. 1.3 Renal biopsy conforms to the pathological changes of DKD. 2 . Serum potassium concentration = 5mmol/l and eGFR = 25ml/min/1.73 ? before enrollment; 3 . Able to understand and follow relevant research instructions.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Type 1 diabetes, secondary diabetes, diabetes acute complications (diabetes ketoacidosis, etc.) in the last three months; 2. Continuous use of other mineralocorticoid receptor antagonists such as spironolactone and eplerenone, any renin inhibitors, and potassium sparing diuretics; 3. Continuous use of potent cytochrome P450 3A4 inhibitors or inducers; 4. Serious systemic diseases such as heart, liver, kidney, blood, cerebrovascular, active or untreated malignant tumors, mental and psychological disorders, endocrine disorders, etc; 5. has received or plans to receive a kidney transplant; 6. Untreated or poorly controlled hypertension: mean sitting systolic blood pressure = 160mmHg or mean sitting diastolic blood pressure = 100mmHg; 7. Patients with concomitant chronic or acute infections; 8. Known or possibly allergic to non nifedipine active ingredients or any excipients; 9. Breastfeeding women or pregnant women.

Design outcomes

Primary

MeasureTime frame
urinary albumin/creatinine ratio;24-hour urinary protein ;urinary ß2-microglobulin;interleukin-1ß;interleukin-6;

Secondary

MeasureTime frame
creatinine;serum potassium;glycosylated hemoglobin;blood fat;alanine aminotransferase;aspartate aminotransferase;

Countries

China

Contacts

Public ContactAiGe Yang

The First Hospital of Hebei Medical University

57400232@hebmu.edu.cn+86 186 3388 9607

Outcome results

None listed

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