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Huangkui capsule combined with finerenone for the treatment of type 2 diabetes mellitus complicated with chronic kidney disease A multicenter randomized double-blind clinical study of efficacy and safety

Huangkui capsule combined with finerenone for the treatment of type 2 diabetes mellitus complicated with chronic kidney disease A multicenter randomized double-blind clinical study of efficacy and safety

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000053
Enrollment
Unknown
Registered
2025-01-10
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Type 2 diabetes mellitus with chronic kidney disease

Interventions

Experimental group:Huangkui capsules
Control group:Huangkui capsules placebo

Sponsors

Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for type 2 diabetes mellitus with a disease duration of more than 6 months; 2) 100=UACR=2000 mg/g 3)e-GFR=30 ml·min-1·1.73m-2 4) Age 18~75 years old (including 18 years old and 75 years old) gender is not limited; 5) The blood pressure is effectively controlled at =140/90mmHg; 6) Glycosylated hemoglobin =9%; 7) treatment with ARB for = 4 weeks without causing unacceptable side effects; 8) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Serum potassium >5.0mmol/L; 2) Blood pressure3×ULN); 6) Those with malignant tumors or malignant diseases that affect the overall prognosis; 7) Patients with primary adrenal insufficiency (Addison's disease); 8) Patients who are allergic to finerenone Huangkui capsule components or any excipients; 9) patients with rare hereditary galactose intolerance lactase deficiency or glucose-galactose malabsorption; 10) Clinically confirmed diagnosis of chronic HFrEF with persistent symptoms at the lead-in visit (NYHA class II-IV; MRA's Category 1A Recommendations); 11) Those who were hospitalized due to stroke transient isch

Design outcomes

Primary

MeasureTime frame
Urine albumin/creatinine;

Secondary

MeasureTime frame
Incidence of abnormal serum potassium;Tumor necrosis factor (TNF-a);Glomerular filtration rate;Transforming Growth Factor (TGF-ß1);Hypersensitive C-reactive protein (hs-CRP);

Countries

China

Contacts

Public ContactZhu Dalong

Nanjing Gulou Hospital

zhudalong@nju.edu.cn+86 13805150781

Outcome results

None listed

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