Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

NCT ID: NCT05753696

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-12-30

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.

Conditions

Proteinuria; Kidney Dysfunction; Blood Pressure; Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

azilsartan group

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

Group Type: EXPERIMENTAL

Azilsartan

Intervention Type: DRUG

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

losartan group

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

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

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

Interventions

Azilsartan

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

Intervention Type: DRUG

Losartan

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhida Chen

Role: PRINCIPAL_INVESTIGATOR

The second afiliated hospital of zhejiang university, school of medicine

Locations

the Second Afficiated Hospital, Zhejiang University, School of Medicine

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhida chen, Dr

Role: CONTACT

715264276@qq.com

15168417788

Facility Contacts

Zhida Chen

Role: primary

References

Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

Reference Type: DERIVED

PMID: 38682786 (View on PubMed)

Other Identifiers

2022-106

Identifier Type: -

Identifier Source: org_study_id