Efficacy and Safety of Azilsartan plus Tripterygium and its Extracts for Hypertensive Nephropathy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300069431

Enrollment

Unknown

Registered

2023-03-16

Start date

2023-04-01

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Hypertensive Nephropathy

Interventions

Group B:Azilsartan + Placebo

Group C:Azilsartan Plus Tripterygium and its extracts

Group A:Irbesartan + Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Understand and have signed the informed consent; 2. Systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg without medication, or patients with grade II and above hypertension undergoing antihypertensive therapy; 3. The estimated glomerular filtration rate(eGFR) 300 mg/g; 5. No cardiovascular and cerebrovascular events in four weeks; 6. Negative pregnancy test and willing to contraception during treatment.

Exclusion criteria

Exclusion criteria: 1. Children, pregnant or nursing patients; 2. Secondary hypertension, such as Cushing's disease, primary hyperaldosteronism, pheochromocytoma, etc.; 3. Renal insufficiency caused by other causes, such as diabetic nephropathy, idiopathic membranous nephropathy, lgA nephropathy, etc.; 4. eGFR < 30 ml /min·1.73m2; 5. Patients with severe infection, malignant tumor or immune system disease; 6. Patients with myocardial infarction or stroke within 6 months before the start of the trial; 7. Patients with liver insufficiency (alanine aminotransferase more than 3 times the healthy limit); 8. Patients with white blood cell count < 3.0 × 10^9/L, or anemia (hemoglobin level less than 80 g/L), platelet count less than 80 × 10^9/L, or other blood disorders; 9. Patients with a history of allergy to the ingredients used in the study or contraindications of the drugs used in the study; 10. Patients with dementia, mental abnormality or any mental illness that interferes with the understanding of informed consent.

Design outcomes

Primary

Measure	Time frame
urine albumin-creatinine ratio;Serum creatinine;Urea Nitrogen;eGFR;systolic pressure;diastolic pressure;	—

Secondary

Measure	Time frame
Plasma albumin;Liver function;Blood routine examination;Serum electrolytes;	—

Countries

China

Contacts

Public ContactHuang Hui

The Eighth Affiliated Hospital, Sun Yat-Sen University (Shenzhen Futian)

892986433@qq.com+86 139 2373 0765

Outcome results

None listed

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