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A single-center randomized crossover controlled trial to evaluate the efficacy and safety of azisartan in the treatment of proteinuria and renal function in non-dialytic hypertensive patients with IgA nephropathy

A single-center randomized crossover controlled trial to evaluate the efficacy and safety of azisartan in the treatment of proteinuria and renal function in non-dialytic hypertensive patients with IgA nephropathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076082
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

IgA nephropathy

Interventions

experiment group 1:The first 12 weeks after taking azilsartan to valsartan
experiment group 2:After taking valsartan in the first 12 weeks, it was changed to azilsartan.

Sponsors

Chinese Cardiovascular Association-HX Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 ) Voluntary signing of informed consent. 2 ) Age 18-75 years old. 3 ) Non-dialysis patients diagnosed with IgA nephropathy by renal biopsy. 4 ) 24-hour urine volume > 1000ml 5 ) 24-hour urinary protein > 0.5g or urinary ACR>300mg/g.

Exclusion criteria

Exclusion criteria: 1 ) Fertility non-contraceptive, pregnant or lactating women. 2 ) severe hypertension ( msDBP = 110 mmHg and / or msSBP = 180 mmHg ). 3 ) Neurovascular edema, drug-related or other causes reported by patients. 4 ) Patients currently diagnosed with heart failure ( NYHA class III-IV ). 5 ) LVEF 6.0mmol / L during the visit ; aLT or AST > 2 times the upper limit of normal ( ULN ) or TBL > 2 xULN or ALP > 1.5 xULN. 13 ) The researchers believe that there are no provisions in the program that may pose a high risk to patients, or prevent patients from complying with the requirements of the study and any medical or surgical conditions that cannot complete the study.

Design outcomes

Primary

MeasureTime frame
ACR;

Secondary

MeasureTime frame
eGFR;24-hour urinary protein;LVEDD;Left ventricular posterior wall thickness;

Countries

China

Contacts

Public ContactChen Junzhe

The Third Affiliated Hospital of Southern Medical University

chenjunzhe0304@163.com+86 130 6635 4522

Outcome results

None listed

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