Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05753696

Collaborator

(none)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proteinuria Kidney Dysfunction Blood Pressure Diabetic Kidney Disease	Drug: Azilsartan Drug: Losartan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: azilsartan group the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day	Drug: Azilsartan Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d
Active Comparator: losartan group the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day	Drug: Losartan losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d

Arm

Intervention/Treatment

Experimental: azilsartan group

the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day

Drug: Azilsartan

Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d

Active Comparator: losartan group

the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day

Drug: Losartan

losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d

Outcome Measures

Primary Outcome Measures

proteinuria [up to 16 weeks]
urinary protein

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.