Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Not Applicable

Recruiting

• Conditions: Proteinuria; Kidney Dysfunction; Diabetic Kidney Disease; Blood Pressure
• Interventions: Drug: Azilsartan; Drug: Losartan

• Registration Number: NCT05753696
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-22
• Last Update Submitted: 2023-02-22
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03
• Study Start: 2023-04-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azilsartan group	Azilsartan	the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day
losartan group	Losartan	the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day

Primary Outcome Measures

Name	Time	Method
proteinuria	up to 16 weeks	urinary protein

Secondary Outcome Measures

Name	Time	Method
blood pressure	up to 16 weeks	bp
24 hour urine protein	up to 16 weeks	24 hour total protein
kidney function	up to 16 weeks	creatine, Blood Urine Nitrogen
urinary albumin/ creatine	up to 16 weeks	urinary albumin/ creatine

Trial Locations

Locations (1)

the Second Afficiated Hospital, Zhejiang University, School of Medicine; 🇨🇳 Hanzhou, Zhejiang, China