Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Kidney Disease; Proteinuria; Blood Pressure; Kidney Dysfunction
• Intervention / Treatment: Drug: Azilsartan; Drug: Losartan

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zhida chen, Dr; Phone Number: 15168417788; Email: 715264276@qq.com

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Recruiting
      • the Second Afficiated Hospital, Zhejiang University, School of Medicine
      • Contact: Zhida Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proteinuria	urinary protein	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urine protein	24 hour total protein	up to 16 weeks
blood pressure	bp	up to 16 weeks
kidney function	creatine, Blood Urine Nitrogen	up to 16 weeks
urinary albumin/ creatine	urinary albumin/ creatine	up to 16 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zhida Chen, The second afiliated hospital of zhejiang university, school of medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: hypertension; diabetic kidney disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Urination Disorders; Hypertension; Kidney Diseases; Diabetic Nephropathies; Proteinuria; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan; Azilsartan medoxomil
• Other Study ID Numbers: 2022-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No