NCT05753696

Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

The Effect of Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.

Conditions

• Proteinuria
• Kidney Dysfunction
• Blood Pressure
• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	Azilsartan	Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d
DRUG	Losartan	losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-10-30
• Completion: 2024-12-30
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: China