Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753696
• Other study ID #: 2022-106
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: zhida chen, Dr
• Phone: 15168417788
• Email: 715264276[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 30 to 70;
• Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%;
• The patient's blood pressure Systemic Blood Pressure (SBP) >140 or Diastolic Blood Pressure (DBP) >90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs;
• Urine albumin/creatinine ratio>300mg/g.

Exclusion Criteria:

• Type 1 diabetes;
• The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease;
• Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients;
• It is expected that dialysis treatment will be carried out within 6 months;
• Patients with malignant tumors;
• Patients with mental illness;
• The researcher believes that others are not suitable for this study.

Related Conditions & MeSH terms

• Blood Pressure
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Hypertension
• Kidney Diseases
• Kidney Dysfunction
• Proteinuria

Intervention

Drug:
• Azilsartan
Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d
• Losartan
losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d

Locations

Country	Name	City	State
China	the Second Afficiated Hospital, Zhejiang University, School of Medicine	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteinuria	urinary protein	up to 16 weeks
Secondary	24 hour urine protein	24 hour total protein	up to 16 weeks
Secondary	blood pressure	bp	up to 16 weeks
Secondary	kidney function	creatine, Blood Urine Nitrogen	up to 16 weeks
Secondary	urinary albumin/ creatine	urinary albumin/ creatine	up to 16 weeks